Quality

Legend Biotech

Sr. Manager Quality IT

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a **Sr Manager, Quality IT** as part of the **Quality IT** team based in **Bridgewater, NJ.**

**Role Overview**

The Sr Manager, Quality IT is responsible for providing IT Quality oversight for the implementation and lifecycle management of GxP IT systems within Legend Biotech. Duties include, but are not limited to interpreting applicable regulations, defining IT QA requirements and implementing processes and procedures at Legend that comply with regulatory guidelines and company standards. This position will ensure that GxP electronic systems adhere to both national and international regulatory guidelines on Electronic Records, Electronic Signatures, Data Integrity, cGMP, GCP, GLP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines

**Key Responsibilities**

- Ensure that GxP IT systems, processes and records adhere to Legend CSV and SDLC procedures, FDA, EMEA and other regulatory requirements.
- Provide IT Quality oversight for GxP System enhancement and validation activities inclusive of documentation and change controls.
- Contribute to the development and enforcement of applicable standard operating procedures at Legend.
- Work with cross-functional teams for System upgrades, maintenance, and recommendations for purchasing software, working with the relevant departments to develop user requirements and ensuring regulatory compliance.
- Assist in the development and coordination of Software Validation Plans; Installation, Operational and Performance Qualification protocols and reports; System Risk Assessments, Standard Operating Procedures; and Requirements Traceability Matrices.
- Maintain master files, profiles and tables for multiple software applications and drive harmonization across systems.
- Review and approve IT systems change management documentation, authorizing system use upon verification that requirements are met.
- Monitor error reports and assure data integrity. Investigate and document application problems and recommend system and/or procedural changes.
- Support and maintain the annual IT supplier audit program.
- Ensure audit observations, deviations, CAPAs are communicated, tracked, and remediated, in compliance with internal policies and procedures as well as with all applicable regulatory requirements.
- Provide Quality oversight for SOPs governing use and validation of IT Systems.
- Identify and mitigate risks associated with GxP IT systems and processes, developing strategies to address compliance risks.
- Train IT personnel and key stakeholders on GxP requirements and standards for computerized systems.
- Support continuous improvement efforts through the monitoring of process performance and metrics.
- Assist with inspection readiness efforts and program implementation and support GxP regulatory inspections as required.
- Support Legend’s regulatory program and monitor the regulatory landscape to stay informed of regulatory trends and developments.
- Support development and gathering of quality metrics for Legend’s Quality Management Review (QMR).
- Require minimal directions to complete tasks, knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes.
- Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
- Routinely recognize and resolve quality issues or data trends. Seek management guidance on complex issues.
- Ability to quickly process complex information and often make critical decisions with limited information with minimal oversight.
- Establish key stakeholder relationships with all Legend Leadership Team, Legend Functional Leads, Legend Project Management, Legend Quality and Legend IT.

**Requirements**

- A minimum of a Bachelor’s degree in Science, IT, Engineering or equivalent technical discipline. Advanced degree preferred.
- 10+ years of relevant work experience within a pharmaceutical / biotech or medical device industry with min 5 yrs leadership experience is required.
- Experience collaborating and communicating effectively with internal and external stakeholders
- Proficiency in QMS software, document control, validation tools, change control systems, LIMS, Veeva, ERP systems (SAP considered a plus)
- Ability to clearly represent compliance requirements and drive continuous improvement following risk-based approaches
- Highly motivated, flexible, and excellent organizational skills
- Experience working in Quality Assurance, Quality Systems and/or IT
- Strong knowledge of global GxP regulations (US is a must; EU, China and GTP are considered a plus)
- Excellent verbal and written communication skills
- Ability to prioritize and balance work from multiple projects in parallel
- Regulatory Agencies firsthand inspection experience considered a plus
- Clinical, GMP and GLP audit experience considered a plus.
- **AI Literacy**: Possesses a working knowledge of AI technologies and approved AI tools, applies them responsibly to enhance productivity and decision-making, exercises appropriate human oversight of AI-generated outputs, and complies with organizational policies governing AI use.

\#Li-BZ1

\#Li-Onsite

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$127,313 - $167,099 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

New Jersey

Director, QA Operations

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a **Director, QA Operations** as part of the **Quality** team based in **Raritan, NJ.**

**Role Overview**

The Director of Quality Operations, CAR-T is responsible for Quality oversight and support of cell therapy manufacturing operations, in full compliance with established cGMP requirements. Functions and activities include Disposition activities, including incoming materials and final drug product, QA shop floor oversight of manufacturing operations, Quality Assurance review and approval functions, and QC laboratory oversight, among others. The role develops and implements long-term and execution of Quality programs. This role will also be responsible for trending of quality operations metrics and developing continuous improvement initiatives for the team and processes. The Director also manages a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and developing capabilities.

**Key Responsibilities**

- Manage the daily quality activities for the quality operations team to ensure facility, process, and materials are in compliance with cGMP requirements.
- Partners with other Legend functional leaders to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems.
- Responsible for all aspects of incoming and final product disposition for the site.
- Responsible for batch record review activities for the site.
- Oversees quality shop floor program to ensure compliance of the manufacturing operations.
- Responsible for providing quality oversight of the QC laboratory.
- Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility.
- Manages team of senior managers and professionals within Quality. Hires and develops employees within the department.
- Coordinates quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes.
- Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectively linked.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.

**Requirements**

- A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
- A minimum of 14 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
- Strong interpersonal and written/oral communication skills.
- Proven people management and leadership experience is required.
- Experience working with quality systems is required.
- Extensive knowledge of chemical, biochemical and microbiological concepts is required.
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.
- Ability to quickly process complex information and often make critical decisions with limited information.
- Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
- Proficient in applying process excellence tools and methodologies.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a requirement.
- Experience developing and setting long-term objectives.
- Ability to identify/remediate gaps in processes or systems
- Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).

\#Li-BZ1

\#Li-Onsite

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$193,629 - $254,137 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

QA, Shop Floor Specialist II

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a **QA Shop Floor Specialist**  **(2nd Shift)**  as part of the **Quality** team based in **Raritan, NJ.**

**Role Overview**

The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

**Key Responsibilities**

- Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.
- Support manufacturing activities for cGMP compliance through spot checks/internal audits.
- Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
- Review of all documentation, in accordance with Good Documentation Practices (GDP).
- Review, revise, or draft Standard Operating Procedures (SOPs)
- Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised.
- Support batch review & material release in SAP for In-house reagents.
- Support Floor Spot-check, audit trail review.
- Strive to reduce non-conformances in supported areas by proactively driving compliance.
- Support Investigations team by providing quality and compliance input for continuous improvement and remediations.
- Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor.
- Utilize multiple electronic quality systems, batch records and SAP.
- Work in a team based, cross-functional environment to complete tasks required to meet business objectives.
- Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas.
- Provide QA shop floor support for extended periods of time.
- Responsibilities will include but not limited to tasks mentioned above.
- Support regulatory inspections and audits as needed.
- Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.
- Other duties will be assigned, as the need arises.
- Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
- Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.
- Color Perception both eyes 5 slides out of 8.

**Requirements**

- Bachelor’s degree required in Life Sciences or Engineering.
- 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience
- Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy.
- Experience with quality support in clinical manufacture is preferred.
- Flexible to work on weekends, as needed.
- Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
- Is frequently required to communicate with coworkers.
- While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms.
- Ability to lift 20 lbs.
- Report to work on-time.
- Duties are required to be performed on-site at manufacturing facility.
- Perform other duties as assigned.
- Attend departmental and other scheduled meetings.
- Practice good interpersonal and communication skills.
- Demonstrate positive team-oriented approach in the daily execution of procedures.
- Promote and work within a team environment.
- Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
- Support and contributes to projects.
- Assist in troubleshooting issues related to manufacturing.
- Technical knowledge within functional units
- Demonstrate an understanding of the process in order to properly perform the assigned tasks.
- Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems.
- Utilizes tools within MS Office and other systems to improve business effectiveness.
- Read and interpret documents such as safety rules, operating instructions, and logbooks.
- Review and provide feedback for SOPs.
- Interpret a variety of instructions furnished in written, oral, or diagram.
- Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process.
- Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals.
- Aseptic processing in ISO 5 clean room and biosafety cabinets.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
- Great attention to detail and ability to follow the procedures.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a must.
- Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
- Ability to collaborate well with stakeholders, customers and peers.
- Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
- Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
- Ability to manage conflict and issues that arise with internal or external customers.

\#Li-RN1

\#Li-Onsite

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$78,251 - $102,705 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a **QA Shop Floor Specialist** as part of the **Quality** team based in **Raritan, NJ.**

**Role Overview**

The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

**Key Responsibilities**

- Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.
- Support manufacturing activities for cGMP compliance through spot checks/internal audits.
- Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
- Review of all documentation, in accordance with Good Documentation Practices (GDP).
- Review, revise, or draft Standard Operating Procedures (SOPs)
- Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised.
- Support batch review & material release in SAP for In-house reagents.
- Support Floor Spot-check, audit trail review.
- Strive to reduce non-conformances in supported areas by proactively driving compliance.
- Support Investigations team by providing quality and compliance input for continuous improvement and remediations.
- Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor.
- Utilize multiple electronic quality systems, batch records and SAP.
- Work in a team based, cross-functional environment to complete tasks required to meet business objectives.
- Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas.
- Provide QA shop floor support for extended periods of time.
- Responsibilities will include but not limited to tasks mentioned above.
- Support regulatory inspections and audits as needed.
- Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.
- Other duties will be assigned, as the need arises.
- Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
- Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.
- Color Perception both eyes 5 slides out of 8.
- Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.

**Requirements**

- Bachelor’s degree required in Life Sciences or Engineering.
- 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience
- Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy.
- Experience with quality support in clinical manufacture is preferred.
- Flexible to work on weekends, as needed.
- Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
- Is frequently required to communicate with coworkers.
- While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms.
- Ability to lift 20 lbs.
- Duties are required to be performed on-site at manufacturing facility.
- Perform other duties as assigned.
- Attend departmental and other scheduled meetings.
- Practice good interpersonal and communication skills.
- Demonstrate positive team-oriented approach in the daily execution of procedures.
- Promote and work within a team environment.
- Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
- Support and contributes to projects.
- Assist in troubleshooting issues related to manufacturing.
- Technical knowledge within functional units
- Demonstrate an understanding of the process in order to properly perform the assigned tasks.
- Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems.
- Utilizes tools within MS Office and other systems to improve business effectiveness.
- Read and interpret documents such as safety rules, operating instructions, and logbooks.
- Review and provide feedback for SOPs.
- Interpret a variety of instructions furnished in written, oral, or diagram.
- Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process.
- Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals,
- Aseptic processing in ISO 5 clean room and biosafety cabinets.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
- Great attention to detail and ability to follow the procedures.
- The candidate must be highly organized and capable of working in a team environment with a
  positive attitude under minimal supervision.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a must.
- Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
- Ability to collaborate well with stakeholders, customers and peers.
- Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
- Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
- Ability to manage conflict and issues that arise with internal or external customers.

\#Li-RN1

\#Li-Onsite

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$78,251 - $102,705 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

Supervisor, QC Microbiology

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a **Supervisor, QC Microbiology** as part of the **Quality Operations** team based in **Raritan, NJ**.

**Role Overview**

The Supervisor, QC Micro is an exempt level position with responsibilities for supervising the operation and workflow of the quality control microbiology laboratories in support of cell therapy

manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects.

**Key Responsibilities**

- Ensuring adequate training (skills-based, cGMP and safety) of associates within the department.
- Raw material, in-process, environmental/utility, and product release testing.
- Scheduling of daily activities for personnel.
- Investigation of laboratory non-conformances (events, deviations, and invalid assays).
- Maintenance, calibration and qualification of laboratory instruments and equipment.
- Test method verification, qualification, validation and/or transfer activities in the QC laboratories.
- Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
- Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
- Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
- Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
- Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision.
- Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.
- Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and Planning.
- Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
- Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.
- Color Perception both eyes 5 slides out of 8.

**Requirements**

- A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
- A Minimum of 6 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, or cell therapy. A minimum of 1 year of leadership experience is also required.
- Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development is preferred.
- People management or leadership experience is required.
- Experience working with Quality systems is required.
- Experience with quality support in clinical manufacture or NPI is preferred.
- Extensive knowledge of chemical, biochemical and microbiological concepts is required.
- Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
- Knowledge of cGMP regulations and FDA/EU guidance is required.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Comfortable with speaking and interacting with inspectors.
- Good written and verbal communication skills are required.
- This position may require occasional travel to partner sites in NJ or PA as business demands.
- Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.

\#Li-BZ1

\#Li-Onsite

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

Maintenance Tech I/II

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a **Maintenance Tech I/II (2nd Shift)**  as part of the **Facilities and Engineering** team based in **Raritan, NJ.**

**Role Overview**

This position is responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift (approximately noon–8:30pm). The individual will partner with various Technical Operations functions to support safe, compliant, personalized cell therapy production per cGMP requirements, and will support the organization’s build and ramp-up of clinical production and facility approval of a state-of-the-art cell therapy facility for commercial launch and sustained production. The role requires technical expertise and troubleshooting ability to drive effective, robust production, testing, and release of product to patients.

**Key Responsibilities**

- Diagnose, troubleshoot, repair, and maintain all types of HVAC, clean room HVAC, refrigeration, clean steam, cryogenic storage, and process equipment and systems, applying reactive, preventive, and predictive maintenance and knowledge of plumbing, pipefitting, and millwright activities across related mechanical systems and utilities, with journeyman status in at least one craft.
- Perform minor upgrades and installations of facilities and systems.
- Perform on-site equipment and critical utilities maintenance operations and compliance, including but not limited to support to manufacturing equipment projects, cost-improvement initiatives, asset management, reliability, and business operations.
- Support facility project initiatives as needed.
- Maintain knowledge of and comply with all applicable codes, regulations, and company and/or site policies and procedures.
- Obtain and keep current all required licensing, certifications, and regulatory/job training by promptly completing required training.
- Read and interpret blueprints, P&IDs, and drawings.
- Utilize good documentation practices (GDP) for all work performed on the CMMS system work orders.
- Demonstrated ability to effectively troubleshoot, plan work, anticipate potential problems, and take appropriate actions.
- Demonstrated ability to remove defective parts by dismantling equipment using hoists, scissor lift and manlifts, and hand and power tools.
- Repair instrumentation, electrical devices, circuits, and switchgear used in cGMP and non-GMP systems.
- Investigate, troubleshoot, and provide repairs to equipment, instruments, instrumentation systems, electrical systems, controls, and motors with voltages up to 600 volts.
- Operate, monitor, and maintain switchgear.
- Working knowledge of building automation and environmental monitoring systems, including PLCs, HMIs, VFDs, sensors, and other components, and familiarity with electrical theory, thermal energy principals, mechanical maintenance techniques, and electromechanical theory.
- Familiarity working with validated and qualified equipment and associated documentation required.
- Support maintenance driven quality events including but not limited to Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA’s.
- Support tracking and achievement of annual maintenance goals and objectives including metric improvement targets, and support continuous improvement activities.
- Ensure site compliance with all local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Drug Enforcement Agency (DEA), and Transportation Security Administration (TSA) as applicable.
- Ability to work independently with minimal guidance/oversight.
- Ability to accommodate changes in the schedule including working in other shifts and providing on call support as per operational needs.
- Ability to interact with all levels within the organization.
- Demonstrates willingness to learn new skills, works cooperatively with others, and is available for other duties as required.

**Requirements**

- B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field or minimum of a High School diploma required with equivalent experience.
- Trade / Technical School Certification or Certification in Craft required.
- Military equivalent of Trade / Technical School certification.
- Minimally 8+ years of experience in an industrial manufacturing or regulated environment is required, ideally has cGMP cleanroom manufacturing experience under aseptic conditions.
- Proficiency in more than one craft.
- Experience in the Pharmaceuticals or related industry is preferred.
- Experience working in a controlled, cleanroom environment under aseptic conditions is preferred.
- Experience in HVAC and cleanroom maintenance is preferred.
- Experience with CMMS or similar maintenance management system is required.
- Proficiency in English (verbal and written) and strong communication skills.
- Able to manage shifting priorities to meet critical deadlines in a fast paced, dynamic, and growing environment, with strong analytical, problem solving, critical thinking, and organizational skills.

\#Li-RN1

\#Li-Onsite

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$83,711 - $109,870 USD

**Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.**

**Work Authorization & Employment Eligibility**

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

**EEO Statement**

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](<https://legendbiotech.com/privacy-notice/>).

Tris Pharma

Quality Engineer

**Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs**. We have \>150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

**Located in Monmouth Junction, New Jersey, Tris has an immediate opening for Quality Engineer**

**SUMMARY:**

Quality Engineer supports and assists the Quality Assurance (QA) function by merging product data evaluation under FDA 21 CFR 211.180(e) with technical engineering controls to ensure commercial products consistently meet safety, identity, strength, quality and purity standards. The incumbent leads the statistical trending, data collection and aggregation and drafting of Annual Product Quality Reviews /Annual Product Reviews (APQRs/APRs) to monitor product/process stability and make data-driven continuous improvement across various production processes in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.

**ESSENTIAL FUNCTIONS:**

- Maintains all appropriate Quality related documentation, as assigned while ensuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs
- Leads the evaluation of annual product quality data to identify emerging quality risks, process variability, adverse trends and opportunities for continuous improvement; Utilizes statistical methods and quality risk management principles to transform manufacturing, laboratory and stability data into actionable business and compliance decisions; Collaborates with various departments, functions and appropriate Subject Matter Experts (SMEs) to submit all sub-reports in a timely, accurate and complaint manner
- Hosts APR risk assessment meeting, tracks attendance and takes appropriate actions on team recommendations
- Performs Advanced Trend Analysis for Intermediate, In-process, Finished Product and Stability batches: Evaluates critical quality attributes (CQAs) and critical process parameters (CPPs) using statistical methods; Verifies consistency of existing processes and identifies trends; Properly addresses and reports all negative trends
- Analyzes and interprets large datasets from Manufacturing, Packaging, Laboratory departments, complaints, deviations, Corrective Action Preventive Action (CAPAs), change controls and stability programs to identify statistically significant trends, process shifts and emerging quality risks including, but not limited to: analyzing Deviation and Rejection Profiles, trending manufacturing deviations, batch failures, yield losses and Out-of-Specification (OOS) laboratory findings (i.e., dissolution, uniformity, particle size), etc.
- Applies statistical methods including control charts, process capability analysis, regression analysis, Pareto analysis and trend modeling to evaluate process performance and product lifecycle health
- Evaluates cumulative impact of deviations, CAPAs, change controls, complaints, stability trends, analytical changes and validation activities on product quality throughout product lifecycle
- Recommends revalidation and determines the need for process revalidation or changes to registered specifications based on APQR/APR data and conclusion
- Drives Root Cause Investigations by partnering with QA Investigations, Production, Laboratory, and Technical Services teams to investigate deviations using appropriate tools (i.e., Fishbone, 5 Whys and Failure Mode and Effects Analysis (FMEA)); Mitigates specific product risks by addressing unique technical challenges to company dosage forms and its associated intermediates
- Monitors process capability and calculates and analyzes process indicators such as Process Capability Index (Cpk) and Process Capability Index (Ppk) to monitor process variability
- Maintains all appropriate Quality related documentation, as assigned, while assuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs pertaining to documentation and records management
- Participates in inspections, as needed and supports Regulatory audits by acting as SME for APQRs, trending data and process statistics during FDA and foreign health authority inspections; Assists in other areas of QA and may cross train across department, as needed
- Any other APR tasks assigned by Supervisor or Quality Senior Management

Requirements

**QUALIFICATIONS**

Minimum education and years of relevant work experience

Bachelors degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific discipline and minimum 5 years in quality systems, process validation, product quality review or quality engineering in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility OR combination of education and related quality systems, process validation, product quality review or quality engineering in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility.

Special knowledge or skills needed and/or licenses or certificates **required**

- Deep understanding of FDA 21 CFR Part 210/211, ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10
- Familiarity with laboratory testing equipment such as automated dissolution testers, High Pressure Liquid Chromatography (HPLC), particle size analyzers and viscometers/rheometers, etc.
- Ability to translate statistical observations into quality risk assessments and business recommendations using risk management tools and structured decision-making methodologies
- Proficiency in statistical analysis platforms such as Minitab, JMP or SAS for process trending and control charting
- Demonstrated experience applying statistical methodologies including, but not limited to: Control charting, Process capability analysis, Trend analysis, Regression analysis, Hypothesis testing, Analysis of Variance (ANOVA), Sampling plans, Statistical interpretation of manufacturing and laboratory data, etc.
- Validation Knowledge: Strong foundational knowledge of Process Validation lifecycle stages (Stage 1, 2, and Stage 3 Continued Process Verification). Experience developing, monitoring, and interpreting Continued Process Verification (CPV) data and process performance indicators
- ASQ Certification: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)
- Proficiency with Microsoft Office
- Excellent verbal and written communication and skills
- Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
- Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Excellent planning, organization and time management skills including the ability to support and prioritize stability program
- Fluent in English (verbal and written)
- Ability to identify and distinguish colors
- Ability and willingness to work additional hours as required by business needs

Special knowledge or skills needed and/or licenses or certificates **preferred**

- Experience working with various dosage manufacturing (oral solid or liquid dosages, delayed or extended release products, etc.)
- Lean Six Sigma: Green Belt or Black Belt certification
- Experience with data visualization and reporting tools such as Power BI, Tableau, JMP Live, Spotfire, or equivalent platforms

**Travel requirements**

- 0%

**Physical requirements**

- Office / Laboratory based position
- Ability to lift up to 30 lbs
- Ability to use Personal Protective Equipment (PPE)
- Ability to stand for extended periods

**Anticipated salary range**: $100k – $145k. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities,

Frederick National Laboratory for Cancer Research

Quality Assurance Specialist IV

**Quality Assurance Specialist IV**

Job ID: req4712

Employee Type: exempt full-time

Division: Facilities, Maintenance & Engineering

Facility: Frederick: Ft Detrick

Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

**Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.**

**PROGRAM DESCRIPTION**

The Quality Assurance (QA) Specialist IV – Engineering is a senior-level professional responsible for developing, implementing, monitoring, and continuously improving quality assurance programs, standards, and processes that support engineering, maintenance, reliability, and asset management activities within the Facilities Maintenance & Engineering directorate. This position ensures compliance with organizational policies, engineering standards, regulatory requirements, safety programs, and industry best practices.

**KEY ROLES AND RESPONSIBILITIES**

- Develop, implement, maintain, and enhance quality assurance programs, policies, procedures, and standards supporting facilities such as engineering and maintenance operations.
- Monitor compliance with engineering standards, maintenance procedures, quality management systems, and organizational requirements.
- Serve as a subject matter expert in quality systems, engineering process compliance, risk assessment, performance auditing, and continuous improvement initiatives.
- Evaluate engineering and maintenance processes, identifies risks and deficiencies, recommends corrective and preventive actions, and collaborates with engineering, maintenance, operations, safety, and business teams to improve quality, reliability, and operational performance.
- Review engineering plans, specifications, procedures, and work processes to ensure adherence to applicable codes, regulations, and organizational standards.
- Monitor compliance with safety, environmental, regulatory, and quality requirements affecting facilities engineering operations.
- Monitor and communicate quality performance indicators, audit results, and compliance trends.
- Establish and maintain quality control processes to ensure consistency, reliability, and effectiveness of engineering and maintenance activities.
- Develop, review, and maintain quality-related documentation, including procedures, standards, work instructions, audit reports, and compliance records.
- Ensure document control processes support consistency, traceability, and regulatory requirements.
- Assist in the development and maintenance of engineering standards, technical procedures, and quality manuals.
- Facilitate and support training programs related to quality assurance requirements, engineering standards, compliance obligations, and operational procedures.
- Support the development of quality performance metrics, reporting tools, and continuous improvement initiatives.
- Facilitate continuous improvement initiatives focused on quality, reliability, efficiency, and process standardization.
- Promote a culture of quality, accountability, and operational excellence throughout the department.

**BASIC QUALIFICATIONS**

**To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:**

- Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in Engineering, Quality Management, Industrial Engineering, Facilities Management, Construction Management, Engineering Technology, or a related technical field. Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education requirement, a minimum of eight (8) years of related experience in quality assurance, engineering quality, facilities management, maintenance operations, compliance, or a related field is required.
- Experience conducting audits, risk assessments, compliance reviews, and quality improvement initiatives.
- Experience working within engineering, facilities maintenance, construction, manufacturing, healthcare facilities, government facilities, or similarly regulated environments.
- Strong knowledge of quality assurance principles, quality management systems, and continuous improvement methodologies.
- Knowledge of engineering standards, facility operations, maintenance practices, asset management principles, and regulatory compliance requirements.
- Experience with root cause analysis, corrective and preventive action (CAPA) processes, and risk management frameworks.
- Ability to analyze complex technical and operational processes and identify improvement opportunities.
- Strong understanding of documentation control, audit processes, and compliance monitoring.
- Excellent written and verbal communication skills, including the ability to prepare reports and present findings to leadership.
- Strong organizational, analytical, and problem-solving skills.
- Ability to work independently and manage multiple priorities in a dynamic environment.
- Ability to obtain and maintain a security clearance.

**PREFERRED QUALIFICATIONS**

**Candidates with these desired skills will be given preferential consideration:**

- Preferred Certifications: Certified Quality Engineer CQE), or Certified Reliability Engineer (CRE).

**Commitment to Non-Discrimination**

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

**Pay and Benefits**

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available [here](<https://frederick.cancer.gov/careers/benefits>)

95,100.00 - 136,400.00 USD

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

Maryland

AbbVie

Section Manager, Maintenance & Engineering Services

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

The Section Manager, Maintenance and Engineering Services is responsible for management of the administrative requirements for the department. These responsibilities include personnel management, training management, and project management. This position directly supervises the activities of technical personnel consisting of a mix of exempt and nonexempt employees.

Responsibilities

• Supervises the day-to-day activities of exempt and nonexempt technical personnel. Provides leadership for the organization, and sets direction for all direct reports.

• Responsible for all facets of the Talent Management System (setting goals, growth plans, performance feedback, and performance assessments) for all direct reports.

• Responsible for developing and maintaining department training curriculums for each direct report. Ensures that direct reports complete required training to maintain compliance with job duties and responsibilities.

• Responsible for maintaining adherence to cGMP requirements (training, documentation, procedures, etc.) for the department.

• Supports the department manager in the development of budgets and assists with monthly financial tracking. Supports the department manager in developing Key Performance Indicators for the organization, tracks data related to KPI’s, and drives improvement initiatives across the organization.

• Ensures compliance with all applicable local, state, and federal regulatory requirements which include but are not limited to: OSHA's Process Safety Management (PSM) standard (29 CFR 1910.119) and EPA's Risk Management Planning (RMP) rule (40 CFR 68), Mechanical Integrity programs, PCI, DOT, EPA etc.

• Serves as a project manager for department initiatives and capital projects. Leads members of the organization in the development of the budget, scope, and schedule for major projects.

• Serves as the conduit for communication within the department to ensure that leadership messages, organizational changes, and initiatives are communicated to direct reports. Also serves as the conduit for communication from direct reports back up to the area management.

• Serves as the face of the organization to internal and external customers to ensure communication and customer focus.

• Creates a safety culture by setting direction to reduce or eliminate operations-related injuries or accidents, damage/loss of product or equipment, and unnecessary costs by ensuring that all equipment and facilities are maintained consistent with the safety, security, hygiene and standards set by AbbVie.

Qualifications

• College Degree or equivalent experience. Strong problem solving and analysis skills are required. A technical degree (Engineering or Science) is preferred.

• At least 5+ years of prior experience in area(s) of Manufacturing, Engineering, Maintenance, Facilities Management, or an equivalent Technical Field is required. Prior supervision experience is preferred.

• Knowledge of basic regulatory requirements.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Illinois

Associate Director, R&D Quality Transformation and Data Science

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective medicines and products that solve serious health issues and have a remarkable impact on people's lives. As a quality organization in research development, R&D Quality Assurance is committed to driving quality excellence across all stages of discovery and development for the product's lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients.

Patient needs, stakeholder demands, industry innovation, the regulatory landscape, and AbbVie's business strategy continue to evolve rapidly. Emphasizing and embedding quality in the execution of clinical trials, post-market vigilance, and post-market studies helps assure patient safety, maintain data integrity, foster regulatory compliance, and contribute to the overall success of drug/device development programs.

The Associate Director, R&D Quality Transformation and Data Science supports the development and execution of transformation initiatives across R&D Quality Assurance, integrating digital capabilities, analytics (including AI/ML), process improvement, and operational best practices. This role helps enable the use of data, insights, and emerging technologies to improve quality processes, strengthen quality culture, and support continuous improvement efforts across the organization.

This position is suited for a collaborative and analytical leader passionate about improving how R&D QA operates through data-driven decision-making, process optimization, and change management. The role partners with leaders across R&D Quality Assurance and cross-functional stakeholders to help translate organizational feedback, diagnostic findings, and business needs into practical improvement initiatives. This role reports directly to the Sr. Director, R&D Quality Transformation & Data Science.

**Primary Responsibilities**

1. Support the development and execution of a focused R&D QA transformation roadmap, including analytics, AI/ML, and operational excellence initiatives anchored to organization-wide priorities, regulatory requirements, and diagnostic insights.
2. Analyze survey, diagnostic, and performance data to identify trends, opportunities, and root causes, and help prioritize improvement actions targeting both quality culture and business operations.
3. Lead or support cross-functional transformation projects that improve quality operations, reporting, decision-making and ways of working.
4. Partner with and across R&D QA, IT, and R&D, to implement improvements and support adoption of new tools, methods, and operating models.
5. Contribute to the use of advanced analytics, automation, and AI/ML-enabled solutions to improve efficiency, consistency and insight generation.
6. Support development and refinement of functional KPIs and executive-level dashboards.
7. Support business cases through financial modeling, scenario analysis, quantitative benchmarking, and clear articulation of strategic and operational value.
8. Translate quality and operational data into clear business value narratives, including benefits, cost avoidance, and operational impact of selected improvement initiatives.
9. Monitor progress, risks, dependencies, and outcomes for assigned initiatives, and provide concise status updates and recommendations to leaders and stakeholders.
10. Promote collaboration, change management, continuous improvement, and capability building in digital tools, analytics, and process excellence across R&D QA.

Qualifications

- Bachelors in Data Science, Statistics, Biostatistics, Applied Mathematics, Engineering, Life Sciences, or a related discipline required, advanced degree preferred. Candidates with a Life Sciences degree and an MBA or MS in Analytics are preferred.
- 8+ years of progressive experience in data science, analytics, AI/ML, process improvement, transformation, or operational excellence within life sciences or another regulated industry.
- Experience supporting or leading cross-functional initiatives in pharmaceutical, medical device, combination products, research, development, clinical operations, manufacturing, or quality environments.
- Demonstrated ability to use data, analytics, and structured problem-solving to support process improvement and business decisions.
- Understanding of quality systems, compliance expectations, and transformation/change management principles in regulated environments.
- Strong communication, collaboration, and stakeholder engagement skills.
- Ability to work effectively in a matrixed organization and influence without direct authority.
- Demonstrated expertise in designing and implementing KPI frameworks, balanced scorecards, or enterprise performance management systems.
- Strong statistical proficiency, including regression analysis, Statistical Process Control (SPC/SQC), multivariate analysis, predictive modeling, and hypothesis testing.
- Proficiency in Python, R, and/or SQL, plus experience with at least one BI/visualization platform (e.g., Power BI, Tableau, or equivalent).

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Senior Medical Director, Integrated Medical Quality and Device Safety

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

**Position Summary**

Under the direction of the Head of Quality Risk Assessment and Combination Products within Integrated Medical Quality and Device Safety, Global Patient Safety, the Senior Medical Director, serves as a trusted strategic partner, providing medical quality and device safety expertise to cross-enterprise stakeholders. The scope of responsibility spans the entire AbbVie portfolio, with consultation and accountability that may include product complaints, surveillance, quality risk management and device risk management. The Senior Medical Director is a recognized medical and scientific expert who will work closely with Global Patient Safety (GPS) Therapeutic Area stakeholders to support pipeline enablement and strategic development activities for priority pipeline assets, with responsibility for leading the assessment and management of medical device safety signals, product quality issues, and emerging risks, while providing strategic guidance on benefit-risk evaluations and risk mitigation activities. The role drives proactive identification, interpretation, communication, and mitigation of safety concerns while ensuring alignment with global regulatory requirements and AbbVie's patient safety objectives.

**Key Responsibilities**

Signal Detection and Risk Assessment

- Perform medical assessment of product complaints, adverse events, and product quality issues to determine potential patient impact, reportability, and need for escalation.
- Lead evaluation of safety signals, adverse event trends, and emerging risks from post-market surveillance, literature, clinical studies, and other data sources.
- Contribute to and review Post-Market Surveillance System (PMSS) and Post-Market Clinical Follow-Up (PMCF) activities, ensuring integration of safety data into ongoing benefit-risk assessments.

Medical Quality and Device Safety & Risk Management

- Provide medical expertise for Quality Risk Management (QRM) activities, including benefit-risk evaluations, risk mitigation plans, and cross-functional risk reviews.
- Serve as a medical safety expert accountable for Health Hazard Assessments (HHA) for quality and device-related issues.
- Provide medical input and oversight for Device Risk Management activities throughout the product lifecycle, ensuring risks are appropriately identified, evaluated, monitored and controlled.
- Author, review, and contribute to regulatory submissions, health authority responses, deficiency responses, and other regulatory communications related to device safety, product quality, and risk management.
- Support internal and external inspections, audits, and health authority interactions by serving as a subject matter expert for medical device safety, vigilance, and risk management activities.

Cross-Functional Partnership

- Support process improvement initiatives, procedural development, and implementation of best practices to enhance device safety, surveillance, and quality-related processes.

.

Qualifications

**Required Qualifications**

- MD, DO, or equivalent medical degree with specialty residency and minimum 2 years of patient management experience required.
- Minimum of 3 to 5 years of experience in drug safety, medical device safety, clinical development, pharmacovigilance, regulatory science, or related functions.
- Strong understanding of global medical device regulations, including FDA, EU MDR, and other international requirements.
- Experience evaluating complex safety signals and contributing to cross-functional risk assessments.
- Excellent written, verbal, and presentation communication skills.

**Preferred Qualifications**

- Experience with combination products and connected/digital medical devices.
- Experience supporting regulatory inspections and health authority interactions.
- Advanced understanding of risk management, quality systems, and product lifecycle management

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Other Non-US

Immunocore

Manager, Quality Assurance GCP

Vacancy Name

Manager, Quality Assurance GCP

Vacancy No

VN694

Employment Type

Full Time

Location of role

Gaithersburg, MD, Radnor, PA, Oxford, UK, Remote, US

Department

Clinical QA

Key Responsibilities

The Quality Manager- GCP role will support the execution of Quality Assurance activities within the company, overseeing clinical activities relating to the Quality Management System (QMS), and working closely with internal colleagues to develop systems and processes in-line with regulatory requirements, GCP and internal quality processes, as applicable.

This role will also support GCP internal, external, and supplier audits in accordance with international GCP requirements and Immunocore standards, The Quality Manager (GCP) is responsible for working cross-functionally with stakeholders across the business to support the escalation and management of Quality Issues, Corrective and Preventative Actions (CAPAs), Root Cause Analysis (RCA), as well as ad hoc issues impacting business processes.

The ideal candidate will leverage his/her experience, understanding of GCP, GCLP, GVP and interpersonal skills, to proactively contribute to QA oversight activities leading to QMS, GCP, GCLP, GVP and regulatory compliance. This role will also require someone who can work within a highly innovative, agile and entrepreneurial environment and is able to effectively collaborate while working under pressure to achieve timelines and ensure compliance with QMS and regulatory requirements.

KEY RESPONSIBILITIES

• Perform internal and external audits for clinical activities as defined by the QA Audit Schedule.

• Support the management and oversight of GCP and GVP related activities impacting the QMS.

• Lead or participate in audits of suppliers/vendors to evaluate processes, systems and procedures for compliance to GxP requirements and Immunocore Quality standards.

• Prepare audit plans, perform and report audit findings to the auditee, Head of Functional area and Head of QA.

• Assist in managing core clinical and QA processes including being owner for some agreed QMS processes, as applicable.

• Evaluate and provide oversight for potential risks, standards and quality principles.

• Work cross-functionally with stakeholders across the business to support the escalation and management of Quality Issues, Corrective and Preventative Actions (CAPAs), Root Cause Analysis (RCA), as well as ad hoc issues impacting business processes.

• Support Inspection Management Team in preparation for and management of regulatory authority inspections

• Assist in establishing processes to ensure Data Integrity and communicate the principles of data integrity for GCP.

• Maintain an up-to-date knowledge and log of applicable legislation and regulatory guidelines, including ICH E6 (R3) guidelines.

• Provide in-depth quality reviews of data and documentation, as required.

• Lead or support the development and/or revision of QA processes and procedures including SOPs and risk assessment tools, continuous improvements

• Provide training/mentoring on clinical QA as required.

• Support the review of quality issues and collaborate cross-functionally to ensure risk-based solutions are implemented in a timely manner.

• Partnering with functions to find solutions for Quality Issues and audit findings.

• Travel 30%

OTHER DUTIES

• Participate QA and clinical operational meetings to discuss the status of audits, planned audits, and outstanding CAPAs.

• Support the review of metrics as part of quarterly QMS review meeting.

• Attend and contribute to action items identified as part of weekly Quality Monitoring meetings.

SUPERVISORY RESPONSIBILITY

This position has no supervisory responsibilities

Experience & knowledge

Essential

• Established GCP / QA professional.

• Excellent knowledge of GCP, GCLP, GPvP (GMP an advantage).

• Strong understanding of quality management systems and (GxP), to ensure compliance with regulatory requirements.

• Experience utilizing QMS metrics, KPIs, and QTLs to assess risks to clinical research and drug development processes.

• Knowledge of corporate governance, health care regulations, laws and standards

• Strong collaborative, partnering, and interpersonal skills.

• Previous experience working in clinical research, biotechnology or the pharmaceutical industry.

• Excellent analytical, written and oral communications skills.

• Able to foster support and influence all stakeholders throughout the company.

• Worked with Microsoft Office at an intermediate level (i.e. Word, Excel, PowerPoint Outlook).

• Worked within Quality Assurance in a similar industry for at least 5 years.

Preferred Experience & knowledge

• Previous experience of managing quality systems in the pharmaceutical or biotechnology industry.

• Knowledge of GMP, GLP an advantage.

• Knowledge of the industry/clinical trial process and drug development.

Education & qualifications

• A minimum of 5 to 10 years’ related experience within pharmaceutical and/or biotech industry

• Bachelor’s degree or equivalent combination of education and experience

US Salary Range

$125,000 - $150,000

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Manager, Quality Assurance (12 months FTC)

Vacancy Name

Manager, Quality Assurance (12 months FTC)

Vacancy No

VN886

Employment Type

Fixed Term

Location of role

Oxford, UK

Department

Clinical QA

Key Responsibilities

The Quality Assurance (QA) Manager will primarily provide quality oversight by collaborating with and supporting those departments/functions involved in chemistry, manufacturing and controls (CMC) and good manufacturing practice (GMP) operations pertaining to investigational (IMP) and licensed medicinal products and associated processes at Immunocore.

The QA Manager will work with the established GxP Quality Management System (QMS), with internal colleagues and third parties to ensure the compliance of CMC/GMP processes with the relevant regulatory framework and internal quality requirements.

Where applicable, this role will require the provision of quality oversight and support for departments/ functions/ processes involving research and human tissue management.

Where applicable, this role will influence/ impact wholesale distribution activities and therefore an understanding of the requirements of good distribution practice (GDP) as defined in Directive 2001/83/EC and various national legislation where Immunocore operates, is essential.

Please note this is a 12 months contract.

Key Responsibilities:

• Provide quality oversight and support for:

- CMC and GMP operations, ensuring compliance to the relevant regulatory framework and internal quality processes

- Management of the Product Specification File (PSF) for IMP

- Commercial artwork management

- Validation activities

• Manage the QP batch release/ certification process for the supply of licensed medicinal product and IMP

• Work with and support management of the QMS which may include acting as the process owner for one or more QMS components:

- Document management

- Deviations

- Change controls

- Supplier quality management

- Investigations, root cause analysis (RCA) and CAPA

- Complaints

- Product recall

- Annual product quality review (APQR)

- Quality technical agreements (QTA)/ QP-QP agreements

- Quality risk management (QRM)

- Continuous improvement

• Conduct internal audits of GxP departments/ functions/ processes as lead/ support auditor per the internal audit schedule

• Conduct supplier audits of third party service providers as lead/ support auditor (excluding those requiring a QP) per the supplier audit schedule

• Maintain current knowledge of applicable legislation and regulatory requirements; this includes the critical understanding and interpretation of the above

• Conduct in-depth quality reviews of internal and third-parties’ CMC/ GMP documentation

• Collaborate with relevant stakeholders for oversight of the internal CMC (and where applicable - Research) facilities and outsourced GMP activities

• Provide training on any aspect of CMC/ GMP-Quality as required.

Education, Experience and Knowledge:

Essential Qualifications:

• Bachelor’s degree or higher qualification in a relevant scientific subject

• Trained and/or certified as an auditor to an internationally recognized standard

• 5 years’ experience in the Quality unit within life sciences and/or the pharmaceutical industry

- Practical experience with QMS and compliance to relevant regulatory standards

• Knowledge and/or experience of quality oversight for CMC lifecycle processes

• Knowledge and/or experience of:

- GMP

- pharmaceutical manufacturing processes (advantageous - sterile injectables)

- drug development

• Proficiency in Microsoft 365 applications at an intermediate level

• Excellent written and verbal communication skills

• Experience of fostering support and influencing stakeholders in an organization

• Experience working collaboratively with existing teams

Non-Essential Qualifications:

• Knowledge and/or experience in:

- human tissue management and research

- manufacture of sterile injectable T-cell antigen receptor-based therapeutics produced in microbial/mammalian cell culture platforms

- GDP - operations or QA

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Associate Director, Quality Assurance

Vacancy Name

Associate Director, Quality Assurance

Vacancy No

VN861

Employment Type

Full Time

Location of role

Oxford, UK

Department

Clinical QA

Key Responsibilities

Main Purpose of Job:

Provide operational and leadership continuity across Immunocore's medicinal product lifecycle by deputizing for the Director, Quality Assurance, and supporting the delivery of phase-appropriate, risk-based Quality oversight across chemistry, manufacturing and controls (CMC), good manufacturing practice (GMP), human tissue management and research operations.

As a subject matter expert within the Quality Unit, apply deep technical knowledge to drive inspection readiness, QMS performance, and cross-functional quality oversight across internal and outsourced activities. Provide clear decision-making, appropriate escalation of quality and regulatory risks, and cross-functional collaboration across manufacturing, supply chain, distribution, and R&D interfaces.

Operate with a high degree of autonomy and independent judgement on complex quality matters, recommending best practices and identifying solutions to improve products, processes, and compliance outcomes across the organization.

Where applicable, this role will influence/impact wholesale distribution activities and therefore an understanding of the requirements of Good Distribution Practice as defined in Directive 2001/83/EC and various national legislation where Immunocore operates is essential.

Key Responsibilities:

• Deputize for the Director, Quality Assurance providing continuity of quality decision-making, risk escalation, and cross-functional leadership across manufacturing, supply chain, distribution, and R&D interfaces.

• Act as quality advisor and subject matter expert across the Quality Unit and wider organization, providing guidance on complex quality matters.

• Contribute to the development and execution of the Manufacturing Quality operating plan, including priorities and capability development, in alignment with enterprise Quality strategy.

• Provide quality oversight for CMC and GMP operations across the medicinal product lifecycle, including outsourced QP services, ensuring phase-appropriate compliance with applicable regulations, guidelines, standards, and internal quality processes.

• Support quality governance for Product Specification File (PSF) management and clinical supplies for investigational medicinal products (IMPs).

• Support quality oversight of commercial supply operations, including artwork management.

• Act as Quality lead, or support as required, for critical product quality events, ensuring effective decision-making, communication, and timely execution of containment and remediation actions.

• Support quality oversight of human tissue management operations, ensuring compliance with applicable international standards and ethical requirements.

• Contribute to Immunocore's regulatory inspection readiness program, ensuring quality systems, documentation, and processes are inspection-ready at all times.

• Monitor and analyze QMS KPIs and metrics, identify trends, emerging risks, and systemic opportunities for improvement, and report or escalate findings appropriately.

• Lead or contribute to root cause analysis and CAPA management for quality events, driving timely and effective resolution.

• Identify and recommend best practices or new solutions to improve processes, and/or compliance outcomes across the organization.

• Contribute to regulatory submissions, filings, and responses to regulatory information requests (RFIs), ensuring quality-relevant content is accurate and consistent.

• Partner cross-functionally to ensure effective quality oversight and alignment on shared objectives.

• Proactively engage key stakeholders across the business on complex and unique quality matters.

• Represent the Quality Unit at internal and external meetings, including cross-functional forums, as required.

• Contribute to quality management review processes, providing data-driven input on performance, risks, and improvement opportunities.

Education, Experience and Knowledge:

Essential Qualifications:

• A Bachelor’s degree or higher qualification in a relevant scientific discipline

• At least 8 years’ relevant experience in the biopharmaceutical industry

• Qualified as a lead auditor to a recognized pharmaceutical industry standard

• Extensive knowledge and experience in:

o CMC and GMP operations

o QMS - implementation, management and continuous improvement to ensure GxP compliance with regulatory requirements

o Manufacture of sterile injectable therapeutics produced through microbial and/or mammalian biopharmaceutical processes

(advantageous: experience in T-cell antigen receptor-based therapeutics)

o Drug development

• Ability to collaborate across multiple functions and business areas, aligning diverse teams to deliver Quality and business objectives

• Proven ability to influence, negotiate and engage diverse stakeholders, to drive quality decisions and outcomes

• Advanced written, verbal and cross-functional communication skills

• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).

Preferred Qualifications:

• Experience of working in clinical research

• Knowledge of clinical trials processes.

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Eagle Analytical

Quality Control Chemist

**Job Details**

**Description**

Position Summary

The Quality Control Chemist is responsible for the review, approval, and maintenance of analytical chemistry documentation and quality records to ensure compliance with regulatory and accreditation requirements. This role supports Eagle Analytical’s Quality Management System by reviewing analytical methods, validation documentation, laboratory data, reports, and quality investigations while ensuring adherence to cGMP, cGLP, ISO 17025, A2LA, and USP standards. The position works closely with laboratory operations to maintain data integrity, regulatory compliance, and continuous improvement across chemistry testing functions.

What You Will Do

- Ensure compliance with Eagle Analytical policies, Standard Operating Procedures (SOPs), and the Quality Management System.
- Interpret and apply regulatory and accreditation standards, including ISO 17025, cGMP, cGLP, USP, and A2LA requirements.
- Support regulatory inspections, client audits, and accreditation assessments as required.
- Write, review, and approve SOPs, work instructions, forms, and quality records to ensure regulatory compliance and operational consistency.
- Review and approve analytical test methods and related documentation for chemistry testing, including UV-Vis spectrophotometry, HPLC, HPLC-MS/MS, GC-MS, and other analytical instrumentation.
- Review laboratory test reports, chemistry logs, worksheets, validation protocols, and validation reports.
- Ensure analytical data integrity, accuracy, completeness, and traceability.
- Review and approve quality investigations, including Out-of-Specification (OOS), Nonconformance Reports (NCR), Deviations (DV), Corrective and Preventive Actions (CAPA), change controls, and customer complaints.
- Evaluate root cause analyses and corrective action plans for process and laboratory-related issues.
- Create audit finding reports and determine appropriate corrective and preventive actions.
- Support and conduct internal audits of quality systems and documentation.
- Perform routine walk-through audits to ensure ongoing compliance across laboratory departments.
- Manage auditing, storage, and retention of quality documentation and quarantined materials.
- Prepare and maintain quality-related training materials as assigned.
- Support continuous improvement initiatives related to quality systems, documentation, and laboratory compliance.
- Assist in creating and maintaining quality manuals, procedures, and other controlled quality documents.
- Perform additional duties and special projects as assigned to support quality and regulatory objectives.

Who You Are

- Bachelor’s degree in Chemistry, Analytical Chemistry, or a related scientific discipline required.
- Experience in a regulated laboratory environment (ISO 17025, cGMP, cGLP) preferred.
- Experience supporting analytical chemistry testing laboratories is strongly preferred.
- Strong understanding of analytical chemistry techniques and instrumentation, including HPLC, HPLC-MS/MS, GC-MS, and UV-Vis.
- Working knowledge of method validation, data review, and laboratory quality systems.
- Experience reviewing GMP/GLP documentation and quality investigations.
- Strong attention to detail and commitment to data integrity and compliance.
- Excellent written and verbal communication skills.
- Ability to work independently while collaborating effectively with cross-functional teams.
- Proficiency with Microsoft Office applications and electronic document management systems.
- ASQ preferred

Who We Are

Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results. Learn more at www.eagleanalytical.com.

**Qualifications**

**Skills**

**Behaviors**

**Preferred**

Team Player: Works well as a member of a group

Dedicated: Devoted to a task or purpose with loyalty or integrity

Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well

:

**Motivations**

**Preferred**

Goal Completion: Inspired to perform well by the completion of tasks

Self-Starter: Inspired to perform without outside help

:

**Education**

**Required**

Bachelors or better in Chemistry or related field.

**Preferred**

Bachelors or better in Biochemistry or related field.

**Experience**

**Licenses & Certifications**

**Preferred**

Certification in HPLC

Equal Opportunity Employer

Arizona

United States Pharmacopeia

Quality Assurance Engineer, Digital Products

**Description**

**Who is USP?**

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

**Brief Job Overview**

The Digital & Innovation group at USP is seeking a Quality Engineer who can validate and deliver digital tech solutions. We are seeking someone who excels in digital innovation for building impactful data products across our ecosystem.

**How will YOU create impact here at USP?**

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

**Who is USP Looking For?**

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

**Experience**

- 3-5 years of experience in driving Quality Engineering initiatives across Functional Testing, Automation Testing, Performance Testing
- Good understanding of Performance Engineering methodologies
- Experience working with AI-enabled test automation frameworks and modern automation technologies such as Playwright.
- Ability to drive product-level quality strategies, release test planning, execution governance, integration testing, and quality reporting.
- Collaborate effectively with Product Managers, Engineering Leaders, Architects, Developers, and QA teams to drive continuous quality improvements across the product portfolio.
- Strong knowledge of modern Quality Engineering practices, including Shift-Left Testing, Test Automation, and CI/CD-driven quality processes.
- Demonstrated ability to rapidly learn, evaluate, and adopt new tools, technologies, frameworks, and methodologies to support evolving business requirements.
- Excellent communication, stakeholder management, collaboration, and mentoring skills, with the ability to influence quality outcomes across cross-functional teams.
- Self-motivated, adaptable, and capable of thriving in fast-paced environments with evolving priorities and emerging technologies.

**Education**

- Bachelor’s degree in relevant field (e.g. Engineering, Analytics or Data Science, Computer Science, Statistics) or equivalent experience.

**Supervisory Responsibilities**

None, this is an individual contributor role.

**Benefits**

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

**Job Category** Information Technology

**Job Type** Full-Time

Senior Quality Assurance Engineer, Digital Products

**Description**

**Who is USP?**

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

**Brief Job Overview**

The Digital & Innovation group at USP is seeking a Product Manager who can drive and deliver digital tech solutions. We are seeking someone who excels in digital innovation for building impactful data products across our ecosystem.

**How will YOU create impact here at USP?**

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

**Who is USP Looking For?**

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

**Experience**

- 6-8 years of experience leading and driving end-to-end Quality Engineering initiatives across Functional Testing, Automation Testing, Performance Testing, and Security Testing.
- Proven ability to develop, implement, and govern enterprise-scale performance testing strategies, frameworks, and best practices.
- Good understanding of Performance Engineering methodologies, including Load Testing, Stress Testing, Spike Testing, Volume Testing, Endurance (Soak) Testing, and Scalability Testing.
- Good understanding of Security Testing practices, including Penetration Testing (PT), Web Application Security Testing, API Security Testing, Vulnerability Assessment, and Security Risk Analysis.
- Experience working with test automation frameworks such as Playwright.
- Ability to define and drive product-level quality strategies, release test planning, execution governance, integration testing, and quality reporting.
- Collaborate effectively with Product Managers, Engineering Leaders, Architects, Developers, and QA teams to drive continuous quality improvements across the product portfolio.
- Strong knowledge of modern Quality Engineering practices, including Shift-Left Testing, Risk-Based Testing, Test Automation, Continuous Testing, and CI/CD-driven quality processes.
- Drive quality metrics, defect prevention initiatives, root cause analysis, quality gates, and release readiness assessments.
- Demonstrated ability to rapidly learn, evaluate, and adopt new tools, technologies, frameworks, and methodologies to support evolving business requirements.
- Excellent communication skills, with the ability to influence quality outcomes across cross-functional teams.
- Self-motivated, adaptable, and capable of thriving in fast-paced environments with evolving priorities and emerging technologies.

**Education**

- Bachelor’s degree in relevant field (e.g. Engineering, Analytics or Data Science, Computer Science, Statistics) or equivalent experience.

**Supervisory Responsibilities**

None, this is an individual contributor role.

**Benefits**

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

**Job Category** Information Technology

**Job Type** Full-Time

Novo Nordisk

Quality Control Analyst I - SDF

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including **14 paid holidays**
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Perform & review analysis of in-process, release & stability samples in accordance with cGMP, site & corporate procedures & policies. Transfer of technology & processes in accordance with relevant project plans & timelines.

**Relationships**

Reports to Senior Manager, QC – OFP.

**Essential Functions**

- Accuracy & Scientific Soundness of Lab Data
- Environmental Compliance
- GMP Compliance of Laboratory
- Maintain testing proficiency for methods
- Timeliness of Lab Results & Investigations
- Analysis of Samples
- Supports Deviations
- Follow all safety and environmental requirements in the performance of duties
- Other accountabilities, as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.

**Minimum Qualifications**

- Minimum of a Bachelor’s degree in chemistry or relevant field of study from an accredited university required or an equivalent combination of education and experience
- May consider an Associate’s degree in chemistry or relevant field of study from an accredited university with a minimum of three (3) years of experience in a clinical or industrial/pharmaceutical laboratory
- May consider a High School Diploma or GED with a minimum of five (5) years of experience in a clinical or industrial/pharmaceutical laboratory
- Minimum of one (1) year of experience in a clinical or industrial/pharmaceutical laboratory required
- Must demonstrate attention to detail required

**Preferred Qualifications**

- Ability to author scientific & technical reports a plus
- Able to perform routine testing per SOP & GMP standards a plus
- Basic troubleshooting for laboratory equipment a plus
- Knowledgeable in GMP & laboratory techniques a plus
- Strong communication skills (verbal & written) a plus
- Skills or knowledge in the following discipline: Chemistry Analysis of tablets including UPLC and Dissolution desired

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

North Carolina

Quality Control Analyst III

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including **14 paid holidays**
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Perform & review analysis of in-process, release & stability samples of API and/or filled product in accordance with cGMP, site & corporate policies & procedures. Transfer of technology & processes in accordance with relevant project plans & timelines. Provide leadership for other analysts as they execute their daily tasks.

**Relationships**

Reports to Manager.

**Essential Functions**

- Ensure accuracy & scientific soundness of lab data
- Endure environnemental compliance
- Support & ensure GMP Laboratory Compliance
- Maintain testing proficiency for methods
- Ensure timeliness of lab results & investigations
- Perform analysis of samples
- Author deviations
- Coach other analysts
- Perform data trending & tracking
- Develop process competence across IFP/API
- Drive process improvement for Site QC
- Ensure all Analyst testing of samples is complete, as needed
- Ensure departmental documents are current & standardized
- Perform Laboratory Equipment Validation & System support
- Provide Laboratory IT System support
- Leverage solutions to other NNPILP sites
- Perform deviation & change control activities
- Support other NNPILP sites when relevant
- Support deviations
- Participate in Systematic Problem Solving
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.

**Minimum Qualifications**

- Bachelor’s Degree from an accredited university required
- May consider an Associate’s Degree from an accredited university with seven (7) years of relevant experience in a clinical or industrial/pharmaceutical laboratory required
- Five (5) years of experience in a clinical or industrial/pharmaceutical laboratory required
- Ability to author scientific & technical reports required
- Able to perform routine testing per SOP & GMP standards required
- Advance level knowledge in GMP & laboratory techniques required
- Demonstrate attention to detail required
- Serve as a subject matter expert on QC processes required
- Strong communication skills (verbal & written) required
- Skills or knowledge in one of the following disciplines: Chemistry Analysis (HPLC, UPLC, GC, TOC, AA, UV, PH, KF), Microbiology Analysis (Isolator, Sterility, Bacterial Endotoxin testing, Growth Promotion and Microbial Identification, ELISA, BIOBURDEN) or Raw Materials Analysis (Compendial Testing, FTIR, NIR, Titration and UV-Vis) required

**Preferred Qualifications**

- Advanced level of troubleshooting for laboratory equipment preferred
- Validation & technical transfer experience preferred
- Project Management experience is a plus
- Change control, deviation, trending preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Quality Control Analyst II - SDF

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including **14 paid holidays**
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Perform & review analysis of in-process, release & stability samples in accordance with cGMP, site & corporate procedures & policies. Transfer of technology & processes in accordance with relevant project plans & timelines.

**Relationships**

Reports to Senior Manager, QC – OFP.

**Essential Functions**

- Accuracy & Scientific Soundness of Lab Data
- Environmental Compliance
- GMP Compliance of Laboratory
- Maintain testing proficiency for methods
- Timeliness of Lab Results & Investigations
- Analysis of Samples
- Author Deviations
- Coaching other analysts
- Data Trending & Tracking
- Ensure departmental documents are current & standardized
- Laboratory Equipment Validation & System support
- Laboratory IT System support
- Perform deviation & change control activities
- Supports Deviations
- Systematic Problem Solving
- Follow all safety and environmental requirements in the performance of duties
- Other accountabilities, as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May require corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.

**Minimum Qualifications**

- Minimum of a Bachelor’s degree in Chemistry or relevant field of study from an accredited university required or an equivalent combination of education and experience
- May consider an Associate’s degree in chemistry or relevant field of study from an accredited university with a minimum of three (3) years of experience in a clinical or industrial/pharmaceutical laboratory
- May consider a High School Diploma or GED with a minimum of five (5) years of experience in a clinical or industrial/pharmaceutical laboratory
- Minimum of three (3) years of experience in a clinical or industrial/pharmaceutical laboratory required
- Must demonstrate attention to detail required

**Preferred Qualifications**

- Ability to author scientific & technical reports preferred
- Able to perform routine testing per SOP & GMP standards preferred
- Change control, deviation, trending a plus
- Knowledgeable in GMP & laboratory techniques preferred
- Serve as a subject matter expert on QC processes a plus
- Strong communication skills (verbal & written) preferred
- Troubleshooting for laboratory equipment a plus
- Validation & technical transfer experience a plus
- Skills or knowledge in the following discipline: Chemistry Analysis of tablets including UPLC and Dissolution preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.