Quality

Eli Lilly and Company

Materials Management Quality Assurance

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Overview:**

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Organization and Position Overview**

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Material Management Quality Assurance (MMQA) Principal oversees material/vendor management process ensuring compliance with Lilly Quality Standards and applicable regulatory requirements. They work with supply chain, customer service, procurement, and warehouse operations to assess and approve materials and suppliers. Key responsibilities involve managing programs, facilitating operational enhancements, and providing support for warehouse functions such as material receipt, sampling, and batch release.

**Responsibilities**

- Serve as a materials management expert, mentoring and advising MMQA, Foundry Materials Management, and PR&D.
- Work with business partners and MMQA colleagues to develop processes and strategies to ensure timely release of raw materials, excipients, GMP consumables and packaging components and supplier qualifications to support business needs.
- Oversight and support of qualification of all suppliers of purchased materials (raw materials, excipients, GMP consumables and packaging components) for use in GMP operations.
- Collaborate with site staff and global resources to assist/conduct risk assessments and provide recommendations for Supplier/Service Provider approval.
- Participate in periodic reviews of supplier performance.
- Write and coordinate Supplier, Service Provider, and Affiliate Quality Agreements.
- Represent the voice of quality to material management and supplier certification committees.
- Provide operational oversight for incoming receipt, sampling, and testing.
- Perform batch disposition of incoming materials/consumables.
- Perform SAP data steward functions.
- Review/redline GMP documents including specifications and procedures.
- Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee.
- Support regulatory inspections by providing documentation and Subject Matter Expert support.
- Evaluate potential product quality impact for any GMP-related incident (deviation or change control), perform initial assessment, and support the investigations to ensure proper root cause analysis (RCA) and establishment of effective corrective and preventive actions (CAPA).
- Notify management immediately about any critical departures and make sure the resulting issues are effectively managed.
- Ensure the Foundry is always audit ready and participate in internal/external inspections.
- Perform other related duties as assigned.

**Basic Requirements:**

- Education Level: Bachelor’s degree in a science, engineering, computer-related, or pharmaceutical field, or equivalent industry experience
- 3+ years working in the pharmaceutical industry in Quality Assurance roles
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Preferences:**

- Previous experience working with and managing suppliers and materials in a regulated environment.
- Previous experience with SAP or other inventory/materials management systems.
- Demonstrated knowledge and use of US, EU, Japanese and other regulations as they pertain to areas in the pharmaceutical manufacturing and material/supplier management.
- Experience supporting facility or area start up experience is preferred.
- Skilled in handling deviation and change management records, overseeing evaluation, approval, and complex quality events.
- Demonstrated ability to communicate with and influence cross-functional teams, including good oral and written communication skills.
- Demonstrated strong problem solving and decision-making skills.
- Technical writing experience, including authoring, reviewing, and approving complex GMP documents and quality system procedures.
- Technical aptitude and ability to train and mentor others.

**Other Information:**

- Initial location in Carmel, IN
- Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

\#WeAreLilly

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$66,000 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Indiana

Sr. Principal, Global Quality Systems Business Partner

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Sr. Principal, Global Quality Systems Business Partner is a technical leadership position providing independent oversight of the Global Quality Management System (QMS) Pillars and their corresponding processes (GPOs and global/functional partners), while also acting as the primary quality liaison providing hands-on quality leadership and strategic guidance. This role ensures product quality, regulatory compliance, and continuous improvement are embedded in day-to-day business decisions, while supporting a broad range of QMS pillar process topics and global/functional partners in the development, execution, monitoring of process health, and continuous improvement of the global standards and procedures, ensuring standardized, simple, and compliant processes.

This role consults GPOs, global/functional partners, and network/site leadership on quality assurance matters and proactively assures compliance with regulatory expectations and scientific principles to align quality strategy with operational and business goals. The role engages externally for identifying industry trends and supporting Lilly's external influence initiatives, and engages and influences leadership, global/functional partners, and mentors colleagues in quality principles and culture to develop capabilities within the organization.

**Key Objectives/Deliverables:**

- Provide quality oversight and partner with assigned pillar GPOs and Level 2 (L2) process global/functional associates and leadership to align quality strategy with operational and business goals, supporting the design and continuous improvement of Global Quality Standards, Global Procedures, and related documents and training.

- Provide guidance, coaching, and interpretation of quality expectations to GPOs, global/functional associates, and leadership to ensure robust compliance in managing key technical, quality, and compliance issues.

- Effectively author, review, or approve GxP documents to ensure quality attributes are met and compliant with quality standards through closure (e.g., strategies, standards, procedures, training, protocols, reports, qualifications, specifications, deviations, change controls, CAPA).

- Provide analysis of evolving regulatory and industry expectations, education, training, implementation tools, and emerging technologies to promote simplicity and consistency, ensuring compliance with cGMP, FDA, and other applicable global regulatory requirements.

- Support the monitoring of the health of the QMS through analysis of KPIs, quality metrics, and other performance data, reporting trends and risks to leadership, and support the identification and implementation of continuous improvement initiatives.

- Lead and/or support the assessment, development, and implementation of critical and complex global projects within cross-functional working groups in support of continual and significant quality improvements or technical agenda objectives.

- Engage externally with regulatory or industry forums to share expertise within and outside Lilly through technical publications and presentations
- Support internal/external audits and regulatory inspections, including response preparation as needed.

- Coach and mentor colleagues, including peers, junior associates, and leadership, on key aspects of the QMS, quality principles, quality culture, and regulatory expectations.

- Identify and propose solutions to existing misalignment or potential risks related to the QMS and control strategies to mitigate risk and influence direction on global initiatives, including supporting risk assessments and quality risk management activities across the business unit.

**Basic Qualifications**

· Bachelor's Degree - Preferred in a Scientific Field (e.g., Chemistry, Microbiology, Pharmacy, Engineering)

· 10+ years in pharmaceutical, biotech, or medical device setting

· Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Skills:**

- Strong knowledge and technical expertise in cGxPs and industry guidance in quality management, computer systems, third party quality management, exception handling, document and training management, incident handling, and marketing affiliate operations including cGMP and FDA regulatory requirements relevant to assigned scope.

- Demonstrated cross-functional technical leadership at the global level to influence and contribute to strategy, including the ability to work cross-functionally and influence stakeholders without direct authority during times of ambiguity.

- Strong strategic thinking, leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results while balancing conflicting priorities.

- Proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment.

- Experience leading a major multi-site or global functions improvement initiative.

- Strong project management and organizational skills.

- Demonstrated ability and agility to interpret and apply standards to different situations by understanding partner/leadership needs and applying good problem-solving skills, with strong communication and collaboration abilities.

- Demonstrated ability to write technical documents, develop business presentations, and effectively communicate concepts to a wide range of personnel, including senior leadership.
- Previous experience with designing or executing a scalable/standardized pharmaceutical quality management system among a diverse range of pharmaceutical operations and requirements (e.g., Dry, Parenteral, API, Device, Development, ATMPs), and/or experience with quality systems, governance, metrics, and continuous improvement methodologies.

**Additional Information:**

· Travel - 0-10% Ability to attend training courses, conferences, and both domestic and international for site visits.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$101,250 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

QA - Stat Sort Specialist

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Organization Overview:**

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Concord, North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

**Role Description:**

The QA Specialist – Stat Sort is responsible for providing manual visual inspection of the 100 % inspection Parenteral product units.The QA Specialist – Stat Sort provides support to Operations related to final classification of defects and routine defect investigations.

The QA Specialist – Stat Sort also supports training and qualification of inspection Operators within Concord Parenteral Operations. The QA Specialist– Stat Sort ensures appropriate samples are delivered and documented to the QC Laboratories as well as documenting results of the manual visual inspection results.

**Responsibilities:**

- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
- Ensure Good Documentation practices and compliance with inspection and operational related documents.
- Complete manual visual statistical sorting inspection for Concord Parenteral products in alignment with production schedule.
- Document defect classification information within manufacturing ticket associated with statistical inspection.
- Ensure appropriate sampling of final semi-finished product, delivering the samples to the appropriate laboratories and completing all associated documentation
- Support Operational inspection personnel with completion of required training and qualification activities.
- Support Operations and investigations related to appropriate classification of defects.

**Minimum Requirements:**

- High School Diploma or GED.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

**Additional Preferences:**

- Strong Attention to detail
- Experience in Pharmaceutical Production, QA or QC is desirable
- Demonstrated relevant experience in a GMP facility
- Demonstrated organizational skills
- Proficiency with computer systems including Microsoft Office products, SAP and MES

**Other Information:**

- Position may be required to support off shift activities
- Applicant may work in various areas within the Parenteral Plant.
- Mobility requirements should be considered when applying for this position.
- May be subject to Post Offer Exam
- Must be able to differentiate between colors.
- Must be able to perform tasks requiring near‑vision clarity equivalent to 20/20 at close range, with or without corrective lenses.
- Physical Demands: Light work that requires physical effort. Requires good communication skills, eye-hand coordination and manual skills. Occasionally requires force to raise, to load, and to push objects. Occasionally requires movements of the body like: to incline, to climb, to kneel, to bend, to rise, and to walk down stairs.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$18.02 - $34.90

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

North Carolina

BioMarin Pharmaceutical Inc.

(CW) QC Analyst Contract

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

THIS A CONTRACT ROLE

\*\*\*Shift: Wednesday - Saturday (Onsite 4 days), swing shift (1pm-11:30 pm) \*\*\*

PURPOSE

The Quality Control Analytical In-Process (QCA-IP) Analyst is responsible for performing analytical

test methods on in-process intermediates and varying stages of drug products under minimal

supervision and within cGMP guidelines, to support further manufacturing of commercial and

clinical therapeutics. This role will involve knowledge that includes but is not limited to the

following analyses and concepts: Protein determination by A280, Bradford, UV Absorbance,

Enzyme activity, HPLC/UPLC, and method validation.

CHARACTERISTICS

Functional activities may include: performing a wide variety of analytical assays, maintaining test

sample throughput, monitoring lab supplies, preparing reagents, contributing to process and

method validation studies, supporting investigations and equipment validation, and

brainstorming further development or improvement ideas for procedures.

Work assignments will vary by degree of complexity. Employee is expected to follow SOPs, make

appropriate decisions in daily activities with minimal needs for intervention, and be able to

recognize deviations from routine practices. Incumbent must accurately complete tasks on time

to achieve lab goals, meanwhile limiting GMP / procedural errors, and be capable of accepting

and incorporating feedback. Must also demonstrate the ability to both manage time and

prioritize routine work effectively.

Employee must be able to interpret results against defined criteria, begin to apply critical

thinking to routine work. He/she should demonstrate an ability to evaluate results against trend

QCA-IP Job Profile Analyst

reports, serve some degree of troubleshooting and capacity as trainer, and embrace an active

role in following up on atypical results or issues.

Communication of relevant information must be made to appropriate audiences, and

attendance of necessary team meetings with some participation in discussions is essential.

Employee should also be actively engaged in his/her role, exhibit frequent volunteerism as the

work schedule flow permits and maintain a positive attitude.

RESPONSIBILITIES

1. Timely facilitation of incoming sample receipt and accessioning flow, decipher batch

assignments across all assay types in accordance with agreed upon best practices.

2. Execute analytical methods to facilitate in-process testing under applicable cGMP

guidelines, as well as contribute to the prompt reporting of results to meet the required

timetables of internal customers.

3. Evaluate completed assay validity, calculate and summarize results, analyze data per

expected or specification ranges. Assist with the compilation and verification of trend

analysis reports.

4. Perform and collaborate with co-workers to appropriately share general housekeeping

activity assignments and ensure systems for laboratory maintenance are adequate for

creating a consistent state of inspection readiness.

5. Assist with monitoring and the control of laboratory supply and critical reagent

inventories.

6. Qualify as trainer for specified methods, provide training to less experienced staff.

7. Exhibit proactive communication upon occurrence of compliance risks and deviations

from laboratory procedures, perform initiation of investigation records within required

timeframes.

8. Provide input or assay support to the progression of test method validation,

investigations, technical studies, and method transfer protocols.

9. Attend team huddles and department meetings, generate ideas for laboratory

infrastructure improvements and method optimization.

10. Identify areas to improve operational excellence by reducing non-value-added activities

and increasing process efficiency.

11. Perform other responsibilities as deemed necessary.

QUALIFICATIONS

1. Bachelor of Science degree.

2. 0-3 years of relevant laboratory experience; QC specific experience is preferred.

3. Experience with quality management systems, current Good Manufacturing Practices,

and QC principles.

4. Demonstrated working knowledge with respect to certified functional activities.

5. Good documentation, written and verbal communication skills are essential.

6. Must possess the ability to perform most tasks with minimal supervision.

Page 2 of 3

QCA-IP Job Profile Analyst

7. Computer literacy is required, with proficiency in Microsoft Word and Excel, and

experience in Microsoft PowerPoint preferred.

8. Familiarity with BINOCS or similar scheduling systems is preferred.

9. Familiarity with SAP or similar enterprise systems is preferred.

10. Must have a quality service attitude and focus, exhibit flexibility and willingness to work

additional hours to meet production or laboratory process requirements.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

California

Certinum Labs

Laboratory Director / QC Analytical Chemist (Part-Time)

Certinum Labs is an independent analytical testing laboratory in Fort Lauderdale, FL, specializing in peptide and dietary supplement analysis — identity, purity, and content — by HPLC and LC-MS. We are seeking an experienced analytical chemist to serve as our Laboratory Director and establish our analytical operations.

This is a part-time, flexible position (approximately 2–3 days per week once established), well suited to an experienced analytical/QC chemist who wants an ongoing part-time role bringing an equipped lab into full operation. This is an immediate-start position: the Laboratory Director will lead method development and validation, instrument qualification, and quality-system setup. The setup and validation phase may require additional days, settling into a steady part-time schedule thereafter.

**Responsibilities**  
• Serve as Laboratory Director and technical authority; review and sign Certificates of Analysis (COAs)  
• Review and approve analytical data, methods, and validation documentation; ensure data integrity and investigate out-of-specification (OOS) results  
• Develop and validate HPLC and LC-MS methods (identity, purity, quantification)  
• Establish SOPs, the quality system, and good laboratory practices  
• Oversee instrument qualification (IQ/OQ) and day-to-day analytical operations  
• Supervise analysts and interns

**Qualifications**  
• B.S., M.S., or Ph.D. in Chemistry, Analytical Chemistry, or Biochemistry  
• Hands-on expertise with HPLC and LC-MS (Shimadzu / LabSolutions a plus)  
• Method development and validation experience  
• QC experience and a track record of reviewing/releasing analytical results (COAs) strongly preferred  
• Ability to act as the laboratory’s technical / quality lead

**Details**  
• Part-time, flexible schedule; W-2 position  
• On-site in Fort Lauderdale, FL  
• $55–$100/hour depending on experience and schedule — please share your expected rate when you apply.

To apply, email your CV/résumé to [contact@certinumlabs.com](<mailto:contact@certinumlabs.com>).

Florida

ADMA Biologics

Specialist QA II Manufacturing Oversight

Job Description

**ADMA Biologics** is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a **Specialist QA II Manufacturing Oversight in Boca Raton, FL!**

Job Title: Specialist QA II Manufacturing Oversight

Job Description:

**Position Summary**

The **QA Specialist II - Manufacturing Oversight** will perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.

The QA Specialists team provides 24/7 manufacturing oversight coverage. Specialists are required to work 12-hour shifts (07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM).

**Essential Functions (ES) and Responsibilities**

- Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
- Perform Quality Assurance review and approval of Deviation Reports.
- Possess an understanding cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
- Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
- Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required.
- Review and release of Plasma pools to manufacturing.
- Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
- Review and release of raw materials in LIMS/SAP.
- Perform audits of Nitrogen receipt process.
- Perform notification and disposition of associated Lookback units.
- Assist with quarantining and release of critical systems, equipment, and controlled environments.\\
- Write, review, and revise QA SOPs.
- Review SOPs and documents from other departments and provide feedback as necessary.
- Work with other departments to assess if Deviations, CAPAs, and Change Controls are required.
- Assist with training of new employees.
- Coordinate and perform any additional activities or projects assigned by QA Management.
- Experience with LIMS and SAP preferred.

**Job Responsibilities or Job Requirements**

**Competencies**

Exceptional organizational and communication skills required

Must have excellent writing and oral skills

**Experience Requirements**

**EDUCATION REQUIREMENTS:**

- Bachelor's Degree preferred but can be offset by experience.

**EXPERIENCE REQUIREMENTS:**

- 3-5 years' experience in pharmaceutical or biotechnology industry or other related industry.

**Preferred Experience**

**Compliance Requirements (ES)**

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer:

In addition to competitive compensation, we offer a comprehensive benefits package including:

- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- Company Paid Holidays
- 3 Weeks’ Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit [www.dhs.gov/E-Verify](<https://www.dhs.gov/E-Verify>).

ADMA Biologics is an Equal Opportunity Employer.

Specialist QA I Manufacturing Oversight

Job Description

**ADMA Biologics** is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an **Specialist QA I Manufacturing Oversight in Boca Raton, FL!**

Job Title: Specialist QA I Manufacturing Oversight

Job Description:

**Position Summary**

The **QA Specialist I - Manufacturing Oversight** performs manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.

**Essential Functions (ES) and Responsibilities**

- Possess an understanding of Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
- Perform Quality Assurance review and approval of Event notifications.
- Possess and understanding of cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
- Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
- Review and release of Plasma pools to manufacturing.
- Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
- Perform review and release of raw materials in LIMS/SAP.
- Perform audits of Nitrogen receipt process.
- Assist with quarantining and release of critical systems, equipment, and controlled environments.
- Assist in other oversight activities, as needed.
- Coordinate and perform any additional activities or projects assigned by QA Management.
- Experience with LIMS and SAP is preferred.
- Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers)
- Rotation amongst QA Specialists to provide 24/7 manufacturing oversight coverage. Required to work 12-hour shifts (07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM). Must be available to support coverage on either shift.

**Job Responsibilities or Job Requirements**

**Competencies**

Ability to follow the cGMP’s and procedures with great attention to detail

**Experience Requirements**

**Experience Requirements:**  1-3 years’ experience in pharmaceutical or biotechnology industry or other related industry preferred

**Education Requirements:** Bachelor's Degree preferred but can be offset by experience.

**Preferred Experience**

**Compliance Requirements (ES)**

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer:

**In addition to competitive compensation, we offer a comprehensive benefits package including:**

- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- Company Paid Holidays
- 3 Weeks’ Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit [www.dhs.gov/E-Verify](<https://www.dhs.gov/E-Verify>).

ADMA Biologics is an Equal Opportunity Employer.

Sanofi US

Global Quality Auditor

**Job Title**: Global Quality Auditor

- Location: Morristown, NJ ,Remote

**About the Job**

Ensures that Sanofi Quality and Compliance Standards, and applicable regulatory authorities requirements are met and that all Sanofi sites, Operational Units, affiliates, and third parties achieve, maintain and improve the adequate level of compliance, through independent auditing and follow-up.

Foster best-in-class performance by leveraging data, technology and diverse talents to support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration, Innovation, Expertise.

This critical role:

- Covers all commercial activities.
- Covers Current Good Manufacturing Practice (cGMP), Good Distribution Practice (GDP).
- Supports Sanofis Diverse product portfolio across all GBUs; Specialty Care, Vaccines, General Medicines. Internal and External Auditing (e.g., CMOs, Opella CHC, etc.) and Regulatory Inspections.
- Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products Administration (China), PMDA (Japan), ANVISA (Brazil).

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

**Main Responsibilities**

- Acts as a lead auditor or co-auditor, in accordance with Sanofi processes.
- Supports qualification of new auditors.
- Conducts transversal assessments.
- Prepares, coaches, and supports entities for Regulatory Inspections through varying methods such as unannounced or short-notice visits.
- Participates in External Associations to stay current with emerging trends.
- Evaluates entity risks by developing targeted risk-based agendas and/or advise on mitigations.
- Escalates critical issues and risks.
- Approves/manages CAPAs.
- Participates in Quality Governance Committees (e.g., IRISC) as/when needed.
- Participates in audits and activities with other teams in Sanofi Quality Audit, Inspection, Intelligence & Advocacy as needed.
- May contribute to the creation of departmental QMS such as Training Curriculum, standard audit agendas, and controlled documents.
- **Management**: No direct reports. May lead cross-functional teams for initiatives or projects.
- **Latitude of action**: Highly independent, creative with thoughtful risk taking and compliance mindset.
- **Role impact**: Able to detect evolving trends which will result in adjustment of Sanofi audit and inspection strategy and tactics. Plays a role in transforming the practice of auditing in Sanofi.
- **Scope**: Manufacturing & Supply, Research & Development, Country Offices, Digital, Global Quality organizations in Sanofi, and third parties outside of Sanofi (e.g., Alliance Partners, CMOs, Strategic Vendors, etc.).

**About You**

**Basic Qualifications**

- Bachelors degree in relevant degree in life sciences, pharmacy, engineering, or any field; advanced degree (MSc, PharmD, PhD) preferred.
- 5+ years' experience in quality auditing preferably within the pharmaceutical or biopharma industry.

**Preferred Qualifications:**

- Strong track record in cGMP environments, regulatory inspection support, and risk-based audit methodologies.
- In-depth knowledge of international regulatory requirements and major health authorities including US FDA, EMA, ANSM, NMPA, PMDA, and ANVISA; proficiency in audit methodologies, CAPA management, and risk assessment frameworks.
- Highly independent and self-directed, with a strong compliance mindset and the ability to think creatively while taking thoughtful, calculated risks
- Demonstrated leadership capabilities and cross-functional collaboration skills.
- Willingness and ability to travel domestically and internationally (on average approximately 50%).
- Fluent written and spoken English, for Europe-based role French-speaking preferred.
- Excellent written and verbal communication skills, with the ability to convey complex compliance matters clearly to diverse audiences including site teams and senior leadership.
- Strong analytical and problem-solving capabilities to detect evolving trends and leverage data and metrics to assess quality system effectiveness against governing requirements.

**Why choose us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeks gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SG

\#LI-GZ

\#LI-Remote

\#VHD

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Nationwide

Novo Nordisk

Quality Control Technician (Tues-Sat)

**About the Department**

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications.

What we offer you:

- Leading pay and annual performance bonus for all positions
- 36 Paid days off including vacation, sick days & company holidays
- Health Insurance, Dental Insurance, Vision Insurance
- Guaranteed 8% 401K contribution plus individual company match option
- 14 weeks Paid Parental Leave
- Free access to Novo Nordisk-marketed pharmaceutical products

At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

**The Position**

This role offers hands-on experience in a Microbiology QC lab, supporting the day-to-day activities that keep testing operations running smoothly like: organizing and preparing workspaces, performing routine inspections, perform sampling acitivites, cleaning and sanitization of lab spaces and equipment, and general equipment maintenance. In our GMP and GLP environment the candidate should be detail-oriented, comfortable following established SOPs while diagnosing/fixing issues, contributing to investigations, and maintaining high standards of documentation and compliance. This position requires strict adherence to cGMPs, established manufacturing practices and procedures and compliance with quality regulations and guidelines. Prior experience in a GMP, Life Science, or laboratory environment is preferred but not required. This role will primarily support our Microbiology QC teams.

This is an onsite based position at our West Lebanon, NH bioproduction facility. This is a first shift Tuesday-Saturday schedule.

**Relationships**

Reports to: QC Supervisor (Microbiology)

**Essential Functions**

- Performs routine QC support activities (e.g. housekeeping, sanitizations, glassware cleaning, sample receipt)
- Performs sampling with minimal support
- Support of low complexity tasks (e.g. Spectroscopy, Bioburden Testing, Incoming Inspection of Consumables)
- Performs routine equipment maintenance with support
- Identifies deviations and may support systematic problem solving and laboratory investigations
- Documents and archives work in accordance with Good Documentation Practice
- May support report writing activities
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
- Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
- Other duties as assigned

**Qualifications**

- Education and Certifications:
  - High School Diploma required
  - Associates Degree in a scientific field preferred
- Work Experience:
  - High School Diploma with three (3) years of relevant work experience required
  - Associates Degree with zero (0) years of relevant work experience preferred
  - Pharmaceutical, Biotechnology or other regulated industry experience preferred
- Knowledge, Skills and Abilities:
  - The ability to understand and execute established written instructions is essential
  - Good organizational, time management and documentation skills
  - Attention to detail and ability to prioritize tasks
  - Basic computer skills (e.g. email, MS Word, database management)
  - Knowledge of laboratory or manufacturing operations preferred

**Physical Requirements**

0-5% overnight travel required. The ability to climb, balance, stoop, reach, stand and walk. The ability to push, lift, grasp and feel. The ability to speak, listen and understand verbal and written communication. Repetition including substantial movement of wrists, hands and or fingers. Lifting up to 10 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects. Visual acuity to perform close activities such as: reading, writing and analysing; and to determine the accuracy, neatness and thoroughness of work assigned or to make general observations. The working environment includes a variety of physical conditions including: noise, close proximity to moving parts and equipment, use of ladders and exposure to chemicals; atmospheric conditions including: odours, fumes and dust.

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.

New Hampshire

Siegfried

Site Engineering & Maintenance Head

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

We are seeking a Director of Engineering & Maintenance to lead critical site functions, drive strategic initiatives, and elevate operational excellence across our pharmaceutical manufacturing operations.

This is a leadership role where technical expertise meets strategic vision. As a key member of the Site Leadership Team (SLT), you will play a pivotal role in shaping the future of our site through engineering innovation, capital project execution, and people development.

Deeper fill & finish, sterile medicinal products and facility/maintenance-focused engineering leadership experience is a must!

**Your Profile:**

**Job Description (Your Profile)**

As Director of Engineering & Maintenance, you will:

- Define and execute the mid and long term engineering strategy aligned with site and corporate goals
- Lead major CAPEX projects from concept through execution—ensuring delivery on time, within budget, and to specification
- Establish and drive robust governance processes to track and improve operational performance
- Oversee Engineering, Maintenance, Facilities, Automation, and Calibration teams
- Ensure equipment reliability, asset lifecycle optimization, and KPI performance
- Partner cross-functionally with Manufacturing, M&ST, Quality Assurance, and Project Management
- Support facility expansions, equipment acquisitions, and site modifications, including qualification activities
- Drive continuous improvement in aseptic operations, clean utilities, and GMP compliance
- Lead technical evaluations, equipment selection, and implementation of advanced manufacturing technologies
- Actively contribute to Deviation, CAPA, and Change Control (DCR) processes
- Manage departmental budgets, including CAPEX and maintenance budgets exceeding $3M
- Develop and mentor a high-performing engineering organization

**What You Bring**

- Strong leadership presence with the ability to inspire, develop, and lead technical teams
- Deep expertise across:
  - Pharmaceutical engineering & fill/finish manufacturing of sterile medicinal products
  - Maintenance & reliability systems
  - Automation & process equipment
  - GMP compliance and aseptic operations
- Proven ability to manage complex capital projects and cross-functional initiatives
- Excellent communication skills with the ability to influence at all levels
- Strong analytical mindset with sound decision-making capabilities
- Proficiency with tools such as AutoCAD, SolidWorks, Microsoft Project, Excel, and related systems

**Required Experience & Education**

- Bachelor’s Degree in Engineering (or equivalent)
- 15+ years of engineering experience in the pharmaceutical industry
- 7+ years leading engineering, maintenance, and facilities teams
- 5+ years of GMP experience, including aseptic processes and clean utilities
- Demonstrated ownership of CAPEX and maintenance budgets \> $3M

Target Base Salary: $240,000 – $270,000

*Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications and other job-related reasons.*

**Your Benefits:**

We offer a comprehensive and competitive benefits package designed to support your health, wealth, and work-life balance:

- Medical, dental, and vision coverage (including dependents)
- Life insurance, short and long term disability
- Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
- 401(k) with company match
- Generous Paid Time Off (PTO)

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Quality Assurance Operations Supervisor, Pharmaceutical Manufacturing - 2nd Shift

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

Lead Quality Where It Matters Most

If you've built your career in pharmaceutical manufacturing and enjoy leading people, developing teams, solving problems in real time, and being where the action happens, we'd love to meet you.

As the QA Operations Supervisor, 2nd Shift, you'll lead a team of QA professionals supporting sterile and aseptic manufacturing operations while serving as the primary Quality leader on the production floor. Working closely with Manufacturing, Validation, Engineering, and Microbiology, you'll help ensure products are manufactured safely, consistently, and in compliance with cGMP requirements. Every decision you make helps support our clients and the patients who rely on the treatments we produce.

This is a hands-on, onsite leadership role for someone who thrives in a fast-paced GMP environment, enjoys coaching and developing others, and takes pride in building a strong culture of quality, compliance, and patient focus. You'll spend much of your time on the manufacturing floor partnering with Operations, supporting production activities, and providing real-time quality oversight where it matters most.

**Your Profile:**

**Key Responsibilities**

**Lead & Develop the Team**

- Supervise, mentor, and develop a team of QA Technicians and QA Associates supporting second-shift operations.
- Manage shift staffing, work assignments, priorities, and shift handoffs.
- Provide coaching and leadership that strengthens quality culture, accountability, and team performance.
- Foster a collaborative environment focused on continuous improvement and operational excellence.

**Manufacturing Quality Oversight**

- Serve as the primary QA leader supporting second-shift sterile and aseptic manufacturing operations.
- Provide real-time quality oversight for formulation, compounding, filling, visual inspection, and packaging activities.
- Perform in-process verifications, line clearances, operational observations, and batch record reviews.
- Maintain an active presence on the manufacturing floor to ensure compliance with cGMP requirements, SOPs, data integrity principles, and sterility assurance practices.
- Observe aseptic techniques, gowning practices, and critical interventions to support product quality and patient safety.

**Compliance & Continuous Improvement**

- Support investigations, deviations, CAPAs, and root cause analysis activities.
- Evaluate quality events and partner cross-functionally to resolve issues and drive sustainable improvements.
- Promote Right-First-Time documentation practices and ALCOA+ data integrity principles.
- Monitor quality performance and identify opportunities to strengthen compliance and operational effectiveness.
- Support a culture of continuous inspection readiness.

**Audit & Regulatory Support**

- Serve as a Quality representative during client audits, customer visits, and regulatory inspections.
- Partner with Manufacturing, Engineering, Validation, Microbiology, and Quality Systems teams to maintain compliance and support operational excellence.

**Required Qualifications**

- Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, or a related scientific discipline.
- 4-6 years of experience in Quality Assurance, Quality Operations, or Manufacturing within pharmaceutical, biotechnology, or other GMP-regulated environments.
- Demonstrated supervisory, team lead, or people leadership experience.
- Strong understanding of cGMP requirements, FDA regulations, and quality systems.
- Excellent communication, coaching, problem-solving, and decision-making skills.
- Proven ability to make sound, risk-based quality decisions in a fast-paced manufacturing environment.

**Preferred Qualifications**

- Experience supporting sterile and aseptic manufacturing operations.
- Experience working in a pharmaceutical CDMO environment.
- Knowledge of EU GMP and Annex 1 requirements.
- Experience working within Grade A-D cleanroom environments.
- Familiarity with TrackWise, SAP, LIMS, or other electronic quality systems.
- Experience supporting client audits, customer visits, and regulatory inspections.

**Why Join Us?**

✔ Lead and develop a team of Quality professionals supporting sterile manufacturing operations

✔ Serve as the primary Quality leader for a critical production shift

✔ Join a growing pharmaceutical CDMO committed to quality, innovation, and continuous improvement

✔ Partner closely with Manufacturing, Engineering, Validation, Microbiology, and Site Leadership

✔ Gain valuable exposure to client programs, regulatory inspections, and complex sterile manufacturing operations

✔ Make a direct impact on product quality, compliance, operational performance, and patient safety every day

**Schedule**

**Onsite leading the 2nd Shift Team: 2:00 PM - 10:30 PM**

**Compensation**

**Target Salary Range: $90,000 - $110,000 annually**

*Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.*

**Apply today and bring your Quality leadership expertise to a team where your impact can be seen in every shift, every batch, and every treatment we help deliver to patients.**

**Your Benefits:**

- Medical, Dental, Vision, Life
- Voluntary Accident, Hospital, Pet
- 401K
- Generous Time Off Structure including PTO, Holidays, Sick & Personal

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Manager Quality CQV

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

Responsible for oversight and management of all commissioning, qualification, and validation (CQV) processes for new and existing drug products, medical devices, and manufacturing processes at Siegfried Irvine.

**Your Profile:**

**_Responsibilities_**

- Ownership and management of the overall site validation strategy, rationale, and approach.
- Management of all activities within the scope of the Site Validation master Plan and maintenance of the Site Validation Master Plan, including oversight and approval of qualification activities and documents, including approval of qualification protocols, within the scope of the subordinate validation processes:
  - Facility, Utility, and Equipment Commissioning and Qualification
  - Sterilization Validation
  - Aseptic Process Simulation/Media Fill Validation
  - Manufacturing Process Validation/PPQ Validation
  - Cleaning Validation
  - Analytical Method Validation
  - Computer System Validation
  - Environmental Monitoring Program
- Coordination, management, and oversight of the process validation life cycle process for existing products and for new product introduction projects.
- Coordination of schedule, resources, activities, and deliverable requirements with Project Management, Engineering, MS&T, and Operations for the design, delivery, commissioning, and qualification of facility, utility, and equipment systems as part of new product introductions.
- Coordination of schedule, resources, activities, and deliverable requirements with MS&T and Operations for continued process verification of existing, validated processes.
- Oversight and management of the QA Sterilization Validation group.
- Oversight and management of validation consultants and contractors, where applicable, in support of activities within the scope of the Site Validation Master Plan.
- Ownership, management, and oversight of site GMP training and championing of site GMP culture, including implementation of science-based and risk-based principles, approaches, and decision-making for site CQV processes.
- Participation in change management, deviations, root cause investigations, and other impact assessments to determine impact to and corrective/preventive actions for qualified systems and validated processes.
- Representation of the site CQV program as part of regulatory inspections, client audits, and related activities.

**_Required Knowledge, Skills and Abilities_**

Experience with the commissioning, qualification, and validation activities and processes within the scope of the Site Validation Master Plan.

- Ability to delegate responsibilities and to coordinate activities and responsibilities with other functional areas
- Ability to manage direct reports and to coordinate and manage cross-functional teams
- Ability to analyze and interpret validation test data to determine if processes or systems have met acceptance criteria
- Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision-making and ambition.
- Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
- Leadership Skills: Proven ability to influence others and lead significant change.
- Strong communication skills both written and verbal, including technical writing
- Ability to work on multiple projects simultaneously.
- Proven experience of managing compliance to GMP regulations and guidance. Current working knowledge of cGMPs and an understanding of cleanroom manufacturing environments and related equipment.
- Ability to work consistently and compliantly, following standard operating procedures and quality policies.
- Able to review and approve GMP documentation to a high standard and relating to validation including SOPs, protocols, and reports.

**_Required Education and Experience_**

- Bachelor’s Degree (BA or BS) in engineering, science, or other, related technical discipline
- 6 – 10 years of experience in an FDA or other GMP-regulated environment required
- 6 – 10 years of experience working in the pharmaceutical industry preferred
- 3 – 5 years of supervisory experience managing direct reports and/or managing teams of 5 – 10 people preferred
- Experience working in aseptic manufacturing/cleanrooms preferred

Target Salary Range: $125,000 - 135,000

*Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.*

**Your Benefits:**

- Medical, Dental, Vision
- Flexible Spending & HSA Options
- Life Insurance, Short & Long Term Disability
- Pet Insurance
- Generous PTO, Sick & Holiday Time Off
- 401K

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Quality Assurance Associate I - 2nd Shift

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

The QA Associate I supports the Quality Assurance Operation on the 2nd Shift, which consists of QA Production Floor supports, and QA Product Release.

2nd Shift Hours: 2 PM - 10:30 PM Monday through Friday

**Your Profile:**

**_Responsibilities_**

QA Production Floor Support

- Provide Quality support to Manufacturing personnel on the shop floor for compounding and QA- in-process checks.
- Perform line clearance verification, sterilization chart review, scale calibration verification, and QA in-process checks including but not limited to visual inspection, CSIT/PID test, weight check, and torque test.
- Perform AQL and Level II Visual Inspection for Finished products.
- Prepare in-process samples for submission to the Quality Control laboratory. Support handling of GMP events and initiation of deviation investigations.
- Read, understand, and follow SOP’s and comply with cGMP and GDP.
- Support the issuance of GMP documentation to the Manufacturing floor.

QA Batch Review and Product Release

- Review executed batch records for completeness, accuracy and compliance with approved procedures and Good Documentation Practices (GDP) and resolve discrepancies with manufacturing operators or supervisors.
- Use computerized systems and software such as SAP, LIMS, and TrackWise for data collection and batch record review.
- Enter and verify data from executed batch records into the Product Log Sheet and maintain the database up to date at all times.
- Participate in deviation investigation and CAPA implementation.
- Initiate Certificate of Conformance and prepare executed batch records for product release in a timely manner to meet compliance requirements and business needs.
- Scan and file batch records (physically & electronically).
- Assist in writing and/or revising SOPs to ensure compliance with cGMP and other applicable regulations.

**_Required Knowledge, Skills and Abilities_**

- Working knowledge of QA principles In Pharmaceutical and/or other FDA regulated industries required
- Good computer skills
- Strong attention to detail
- Good oral and written communication skills
- Ability to work overtime and/or work
- on weekend as needed

**_Required Education and Experience_**

- Bachelor's Degree in Biochemistry, Chemistry, Engineering, Biology or closely related discipline required

- 1-2 years' experience in Quality Assurance / Manufacturing environment in Pharmaceutical or other GMP regulated industries required

Target Pay Range: $30-32/hour +10% Differential when working on 2nd Shift (2 PM -10:30 PM)

*Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications and other job-related reasons.*

**Your Benefits:**

- Medical, Dental, Vision, Life
- Voluntary Accident, Hospital, Pet
- 401K
- Generous Time Off Structure including PTO, Holidays, Sick & Personal

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Quality Assurance Manager

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

The incumbent is responsible for the management of all aspects of Quality Assurance and provides daily support and supervision to the Quality Assurance Specialists.

**Your Profile:**

**ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES**:

- Project team member and primary customer contact for quality decisions and product oversight. Liaison for quality issues and execution of product release.

- Executes final release of product, ensuring batches meets all quality specifications and compliance requirements. Added responsibility for on-time release.

- Directs QA resources and workflow with Production and Shipping.

- Sets agenda scheduling and leads audits for external customers. Authors audit responses and ensures completion of associated CAPAs.
- Performs and trains QA staff on performing internal audits

- Provides QA leadership during technology transfers
- Integral to the management of regulatory agency inspections. Incumbent oversees flow of information, is responsible for responding to inquiries and developing strategy for risk mitigation.
- Prepares and tracks KPIs for upper management.
- Authors Standard Operating Procedures/Work Instructions and implements process changes.
- Decision-maker of quality requirements for change controls.
- Designs project scope and compliance requirements for Product and Equipment Validations, Qualifications and Assessments documents. Authors reports with scientifically sound conclusions.
- Acts as the primary liaison between QA and all other departments on day-to-day basis.
- Oversees the flow of logs and turnaround in the Department.
- Ensures QA requirements defined in Customer Quality Agreements are met.
- Acts as the primary contact for projects or issues that involve QA.
- Drives continuous improvement of GMP compliance and inspection readiness
- Participates in Inventory meetings.

- Prepares, reviews and approves Product Quality Reviews (PQRs) / Annual Product Reviews (APRs)

- Reviews and approves change controls and ensure compliance with global change control procedures
- Leads site readiness for regulatory inspections
- Reviews and approves Master Production Records as appropriate.
- Reviews and approves executed logs as appropriate.
- Reviews and approves deviations, investigation reports and CAPAs.
- Reviews and provides input to Drug Master Files (DMFs).
- Manages Customer complaints, inquiries and complete requests pertaining to QA.
- Participates in review and approval of all SOP’s that require QA signature.
- Ensures appropriate training and GMP awareness across site personnel
- Manages implementation and adherence to all applicable cGMP regulations.
- Oversees Quality Systems department
- Manages QA/QS budgets
- Ensures Environmental Monitoring (EM) for the site is on track
- Ensures that personal and departmental moral, ethical, legal, and behavioral conduct meets the Siegfried Code of Conduct.
- Adheres to all applicable SHE regulations.

**SUPERVISION:**

The incumbent directly supervises 5 to 10 QA/QS Specialists and is responsible for staffing, performance management, and training of the direct reports.

**EDUCATION AND EXPERIENCE:**

-A BS degree in Chemistry, Chemical Engineering or equivalent technical field and/or 5-10 years’ experience in Quality Assurance for a pharmaceutical company

-Two to five years of leadership experience is required. In-depth knowledge of cGMP in a manufacturing environment is a must.

**OTHER REQUIREMENTS:**

-Must have excellent verbal and written communication skills.

-Must be able to work efficiently with people of all levels and cultures.

-Must have excellent coaching and interpersonal relationship skills.

-Must be conscientious and detail-oriented.

-Must be a team player.

-Must be a self-starter and initiator.

-Must have excellent project management skills.

**Your Benefits:**

**Additional Benefits**

- Competitive performance-based bonus
- Employee Share Matching Plan
- 401(k) Match
- Medical, Dental, and Vision Offerings
- Life, Sickness and Accident insurance, and Long-term disability
- Increased Voluntary Life Insurance (employee and family) (optional)
- The salary for this role is anticipated to be between $105,000 and $135,000

Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

New Jersey

Sr. Quality Assurance Specialist

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

**Your Role:**

The incumbent assures compliance to all regulatory requirements, current Good Manufacturing Practices, and company Policies, Standard Operating Procedures and Work Instructions.

**Your Profile:**

**ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES**:

- Reviews, approve and tracks executed production records.

- Reviews and approves production and QC investigations.

- Reviews lab sample results and manufacturing records related to qualification/validation activities.

- Conducts, write, and reviews quality related investigations as appropriate.

- Reviews and approves Master Production Records.

- Responsible for cGMP compliance of assigned manufacturing operations / areas.

- Completes QMS items as assigned.

- Is responsible for the conditional / final release of materials.

- Hosts customer and internal audits, as needed

- Conduct internal and external audits, as needed

- Participates in inspections by regulatory authorities

- Writes and reviews Annual Product Reviews/Product Quality Reviews

- Writes and reviews Product Validation / Qualification / Assessments documents.

- Writes and reviews Equipment Qualifications / Assessments documents.

- Writes and reviews Computerized Systems Validations / Assessments documents.

- Reviews, evaluates and approves minor equipment changes.

- Conducts GMP inspections.

- Conducts environmental monitoring.

- Reviews and approves CMC sections of DMFs as appropriate.

- Maintains QA databases for products / equipment as appropriate.

- Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Siegfried Code of Conduct.

- Adheres to all applicable SHE and cGMP regulations e.g. ICH Q7, FDA, 21 CFR 210 and 211, etc.

**EDUCATION AND EXPERIENCE:**

- A BA/BS degree in microbiology, biology, chemistry, or engineering and 3-5 years of experience in QA in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience.

- Thorough knowledge of cGMP in active pharmaceutical ingredient (API) manufacturing is preferable.

**Your Benefits:**

**OTHER REQUIREMENTS:**

- Must have excellent communication skills.

- Must be conscientious and detail oriented.

- Must have excellent computer skills (MS Office 365).

- Must be a team player.

- Must be able to self-manage daily work and set priorities.

- Must be able to manage projects and prioritize appropriately.

- Must be able to adhere to deadlines.
- The salary for this role is anticipated to be between $82,000 and $110,000

Siegfried USA, LLC will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions.

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

Quality Complaint Specialist

**Job Title**: Quality Complaint Specialist

- Location: Swiftwater, PA

**About the Job**

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

**Main Responsibilities**

Supporting the implementation and maintenance of the complaint (Third Party/Product Technical) management process

- Assisting in the management and oversight of the site complaint handling process to ensure timely and effective resolution of product complaints
- Communicating with customers regarding the status and resolution of their complaints
- Documenting and maintaining records of complaint management activities and communications
- Assisting in investigations into product complaints, including root cause analysis and corrective actions
- Collaborating with cross-functional teams to address and resolve complaints
- Analysing complaint data to identify trends and potential areas for product improvement
- Supporting audits and inspections by providing required information related to complaint management
- Ensuring process performance with other entities/sites involved in the management of complaints at the site level

**Key roles (D,A,I) - Key involvement in Decision Making process:**

- Decide on the coordination of specific complaint investigations, ensuring thorough root cause analysis and appropriate corrective actions (D)
- Advise cross-functional teams to address and resolve complaints (A)

**About You**

**Basic Qualifications**

- Bachelor's Degree with 3+ years of experience in Quality Assurance, Quality control, Quality operations, Third party vendor management, complaint management or other related fields.

**Preferred Qualifications**

- Degrees in Life Sciences, pharmaceutical sciences, Engineering or Business are preferred.
- Experience working in the pharmaceutical industry is a plus.

**ExpectedTechnical skills:**

- Ability to analyze complex data sets, identify trends, and draw meaningful conclusions to improve complaint handling processes and product quality
- Excellent verbal and written communication skills to effectively interact with cross- functional teams, regulatory bodies, and customers, and to prepare detailed reports and presentations
- Strong problem-solving abilities to identify root causes of product complaints and implement effective corrective and preventive actions (CAPA)
- High level of attention to detail to ensure accuracy in complaint records, compliance with regulatory requirements, and thoroughness in investigations
- Proficiency in managing multiple projects simultaneously, prioritizing tasks, and ensuring timely completion of complaint investigations and related activities

**Language:**

- Fluent in Reading, Writing, Speaking English

**Why choose us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeks gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SP

\#LI-SP

\#VHD

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Pennsylvania

Insmed Incorporated

QMS Specialist, Quality Assurance

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

Reporting to the Associate Director, Quality Assurance GMP, the QMS Specialist, Quality Assurance, will play a key role in managing QA and Regulatory Compliance activities for Insmed Gene Therapy. This role directly influences Insmed GMP compliance through QA oversight, monitoring and review of Quality System activities. In coordination with the Associate Director, Quality Assurance GMP, primary areas of responsibility include Documentation Review and Monitoring, Review, and Approval of Quality Docs and QMS tasks including Change Controls, CAPAs, Deviations, Document Change Controls, Effectiveness Checks, Periodic Reviews, Quality System Metric Reviews, and related SOPs for these systems. Additional responsibilities include Training Administration for site LMS curricula, such as creation of new user training accounts, monitoring and closure of ServiceNow tickets, updates to training curricula, assignment of training curricula to users, and tracking of trainings coming due.

**What You'll Do:**

In this role,you’llhave the opportunity to oversee the completion of Quality Management System (QMS) records for Insmed Gene Therapy including Document Change Controls, Change Controls, CAPAs, Deviations, Effectiveness Checks, and Periodic Reviews. You'll also:

- Monitor the Learning Management System (LMS) and perform site training administrator tasks, such as creation of new user training accounts, monitoring and closure of ServiceNow tickets, update to training curricula, assignment of training curricula to users, and tracking of trainings coming due.
- Provide input on QMS processes including process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations.
- Support facilitation of Change Control Committee materials and review and approval of changes presented to committee. Facilitate feedback from Change Control Committee Members Perform QA review of Change Controls, CAPA, Deviations, and Effectiveness Checks. Ensure completeness, accuracy, and compliance to all applicable cGMP regulations.
- Handle compilation of quality metrics for trending and follow up for the closure of process improvements. Present and communicate trending reports in respective Quality forums.
- Support training of Insmed Gene Therapy employees in QMS processes.
- Upload and route Quality Records for approval in Veeva Quality Documents electronic documentation system. Perform QA Document Control review and approval of document updates.
- Ensure QMS records comply with process requirements, including use of appropriate document templates, where applicable.
- Review and update SOPs, policies, and standards regularly to ensure compliance with GxP standards, FDA/EMA/ICH and other applicable competent authority regulations and requirements.
- Monitor documents for Periodic Review process and work with document owners to ensure timely document review and update, as applicable.
- Assist in inspection readiness activities and plays a key role during inspections/audits for QMS activities. Provide support during internal review, Audits, FDA Audits, and Third-party consultant Audits.

You will have a minimum of a BS degree in Chemistry,Engineering, LifeScienceor related discipline AND/OR 6years of relevant Quality Assurance experience. You are or you have:

- Direct experience with Change Control,Document Control, Deviations, CAPAs,andEffectiveness Checksin pharmaceutical or medical device products.
- Understanding ofcGMPsfor pharmaceutical products.
- Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
- Experienceworking withan electronic document management system.
- Experience atreviewingprocedural documents,change controls, manufacturing investigations,andlab investigations.
- Demonstrateabilityto manage projects and variable workloads.
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint and Outlook).
- Proficient in analyzing data trends in Excel or Minitab.

**WhereYou’llWork**

This role is based out of ourSan Diegooffice and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

\#

**Who You Are:**

You will have a minimum of a BS degree in Chemistry,Engineering, LifeScienceor related discipline AND/OR 6years of relevant Quality Assurance experience. You are or you have:

- Direct experience with Change Control,Document Control, Deviations, CAPAs,andEffectiveness Checksin pharmaceutical or medical device products.
- Understanding ofcGMPsfor pharmaceutical products.
- Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
- Experienceworking withan electronic document management system.
- Experience atreviewingprocedural documents,change controls, manufacturing investigations,andlab investigations.
- Demonstrateabilityto manage projects and variable workloads.
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint and Outlook).
- Proficient in analyzing data trends in Excel or Minitab.

**WhereYou’llWork**

This role is based out of ourSan Diegooffice and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

\#LI-EG1

\#LI-onsite

**Pay Range:**

$81,000.00-103,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [recruitmentfraud@insmed.com](<mailto:recruitmentfraud@insmed.com>).

Director, Quality Assurance AI/ML Systems

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

The Director of Digital Systems Quality Assurance (DSQA)- AI/ML is an enterprise-level role responsible for representing QA in the design, governance, and continuous improvement of a regulatory-compliant framework for Artificial Intelligence (AI) and Machine Learning (ML) solutions across Insmed’s global GxP-regulated digital landscape. This position serves as the lead for the assessment, classification, risk evaluation, validation, and implementation design of AI/ML-enabled systems, ensuring alignment with global regulatory expectations and Insmed’s quality standards.

Working in close partnership with IT System Owners, Business Owners, and CSV leads, this role drives a unified, risk-based approach to AI/ML quality oversight spanning all DSQA functional domains and Insmed sites. The position serves as the enterprise QA lead for regulated AI/ML solutions, providing independent QA review of Computer Software Validation lifecycle documents and facilitating site IT Change Control processes across all functional areas.

**What You'll Do:**

In this role, you will partner with business stakeholders across Insmed to understand AI/ML use-case needs and translate them into compliant, risk-proportionate QA solutions.

You will also have responsibility for:

- Support AI/ML-specific risk assessment methodologies aligned with GAMP 5, FDA AI/ML guidance, EU AI Act, Annex 11, and 21 CFR Part 11.
- Represent Digital QA in cross-functional governance forums, steering committees, and working groups focused on AI/ML adoption and compliance.
- Support the Development and maintenance of AI/ML-specific validation lifecycle documentation including AI/ML Risk Assessments, Validation Plans, Model Cards, Performance Qualification (PQ) protocols, and Ongoing Performance Monitoring (OPM) plans.
- Ensure responsible AI principles are embedded in the design and governance of AI/ML solutions, including bias assessment, human oversight requirements, and transparency standards aligned with EU AI Act risk classifications
- Ensure AI/ML models and systems deployed in GxP contexts maintain data integrity, auditability, explainability, and traceability in alignment with global regulatory expectations.
- Provide QA oversight and governance guidance for Generative AI (GenAI) and agentic AI use cases in GxP-adjacent environments, including hallucination risk, non-determinism, prompt governance, and output auditability standards.
- Define requirements for ongoing model monitoring, drift detection, retraining governance, and change control processes for AI/ML solutions in validated states.
- Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents.
- Provide guidance, training, and mentoring to the Insmed team members on AI/ML concepts, regulatory expectations, validation approaches, and risk-based QA methodology. Development of AI Training requirements (as necessary)
- Lead or participate in AI/ML-related vendor assessments, audits, and qualification activities to ensure third-party AI/ML solutions meet Insmed’s quality and regulatory standards.Support regulatory inspections and internal/external audits as the AI/ML QA SME; prepare inspection-readiness materials and respond to agency questions on AI/ML topics.

**Who You Are:**

You have a Bachelor’s degree (BS) in Life Sciences, Computer Science, Data Science, Engineering, Pharmacy, or a related scientific or technical discipline required.Advanced degree (MS, MBA, or PhD) in a relevant discipline preferred; candidates with an advanced degree and a minimum of 8 years of relevant experience will be considered

Additionally you have:

- A minimum of 10 years of relevant Quality Assurance experience required; at least 3–5 years in a Director-level or senior leadership capacity.
- Demonstrated experience building, leading, or significantly contributing to AI/ML quality or validation frameworks in a regulated (FDA, EMA, or equivalent) environment.
- Working knowledge of MLOps, AIOps and similar concepts and associated tools and concepts (e.g., model versioning, CI/CD, experiment tracking, drift monitoring platforms); familiarity with cloud-based AI/ML platforms (Vertex, Bedrock) and Data warehouse such as Snowflake preferred.
- Hands-on experience with GxP computer system validation (CSV) and/or Computer Software Assurance (CSA) across multiple domains (clinical, manufacturing, laboratory, commercial).
- Experience as QA reviewer of several GMP records and processes: CSV Validation Protocols, Deviations, CAPA, SOPs, etc.
- Preferred experience in Data Integrity, 21 CFR Part 11, Annex 11, GAMP 5, SDLC (Agile or Waterfall), CSA
- Must have excellent communication skills (verbal and written).
- Demonstrate ability to manage projects and variable workloads.
- Highly organized with a strong attention to details, clarity, accuracy, and conciseness.
- Must successfully exhibit Insmed’s five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies

**Travel Requirements**

This role requires occasional domestic travel approximately 30%

**Where You’ll Work**

This is a hybrid role based out of ourBridgewater, NJ Headquarters.You’llwork remotely most of the time, with in-person collaboration when it matters most.

\#LI-SK1

\#LI-SK - Hybrid

**Pay Range:**

$177,000.00-242,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [recruitmentfraud@insmed.com](<mailto:recruitmentfraud@insmed.com>).

Amgen

Sr Associate QA - Nights

**Join Amgens Mission of Serving Patients**

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

**Sr Associate QA- Nights**

**What you will do**

Lets do this. Lets change the world. In this vital role you will be responsible for Plant Quality Assurance (PQA) On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff, and also to provide coaching, guidance and direction to Manufacturing, Quality Control, and Facilities/Engineering staff regarding compliance and quality systems.

Responsibilities Include:

- Provide Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.
- Provide Quality oversight during on-the-floor analytical testing.
- Ensure that facilities, equipment, materials, processes, and procedures follow cGMPs and other applicable regulations.
- Ensure that deviations from established procedures are investigated and documented per procedures.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Perform review and approval of cGMP processes, procedures, and records, including but not limited to, Standard Operating Procedures (SOPs), batch records, deviations, and logbooks.
- Author, review, and approve quality documents such as risk assessments, training materials, engineering documents, automation documents, protocols, and reports.
- Alert senior management of potential quality, compliance, supply, or safety risks.
- Complete assigned training to permit execution of required tasks.
- Drive operational improvement initiatives, programs, and projects.
- Perform other tasks, as assigned, to assist in completion of activities associated with meeting group, departmental, and company goals

In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule (C shift). The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off and **receiving an added 15% shift differential.**

**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The agile professional we seek is a good collaborator with these qualifications.

Basic Qualifications:

- High school/GED + 4 years Quality Assurance or manufacturing work experience OR
- Associates + 2 years Quality Assurance or manufacturing work experience OR
- Bachelors + 6 months Quality Assurance or manufacturing work experience
- Master's

Preferred Qualifications:

- Experience working in a cGMP environment
- Experience with decision making
- Experience with analytical testing and/or general compendia testing
- Experience working with batch records and other GMP documentation
- Knowledge of data integrity requirements
- Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

**Apply now and make a lasting impact with the Amgen team.**

**careers.amgen.com**

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

**Application deadline**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

**Sponsorship**

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Rhode Island

Syngene International Ltd

Director - Engineering and Maintenance

**Job Title:** Director, Engineering and Maintenance

**Reporting to:** VP, Site Head

**Department:** Engineering & Maintenance

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

*At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.*

**Job Summary**

The Director, Engineering and Maintenance provides strategic and technical leadership across engineering, facilities, and maintenance functions. The Director partners with senior leadership to drive capital projects, continuous improvement, and technology implementation to enhance equipment reliability, site capabilities, and operational performance. The director is accountable for Facilities operations, ensuring maintenance, utilities, and infrastructure are effectively maintained. Additionally, this role establishes engineering standards, supports new product introductions, and builds and develops high-performing team

**Primary Responsibilities:**

- Provide strategic and operational leadership for the Engineering and Maintenance organization
- Oversee Facilities, Utilities, Maintenance, and Engineering functions, ensuring alignment with site and business objectives
- Oversight of capital project planning and execution, including scope development, budgeting, scheduling, and implementation
- Ensure facilities, utilities, and equipment are maintained in accordance with industry best practices and regulatory requirements
- Accountable for all Quality Systems within the Engineering and Maintenance functions, including Deviations, CAPAs, SOP revisions (routine and biennial), and Change Control
- Provide guidance, leadership and directives to support and comply with all health and safety policies and procedures
- Develop and execute departmental goals, strategies, and long-term plans aligned with organizational objectives
- Provide end-to-end technical leadership across design, implementation, and lifecycle management of equipment and systems
- Provide oversight and support for technology transfers, equipment upgrades, and facility expansions
- Establish and maintain engineering standards, best practices, and governance across all systems and processes
- Lead cross-functional teams to drive equipment reliability, operational efficiency, and continuous improvement initiatives
- Serve as a departmental point of contact during internal and external audits and regulatory inspections
- Collaborate with senior leadership to develop business cases, resource plans, and engineering strategies
- Manage departmental budgets, resource allocation, and site capital planning.
- Oversee external engineering contractors, consultants, and service providers
- Support troubleshooting and resolution of complex technical issues impacting manufacturing and facility systems and operations
- Promote professional development of staff through coaching, mentoring, and training

**Education & Qualifications:**

- Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or related field) required
- 10+ years of experience in a biopharmaceutical or biotechnology environment, with leadership experience in engineering and/or facilities management
- Demonstrated career progression with increasing scope of responsibility, leadership, and organizational impact
- Extensive knowledge of cGMP requirements, regulatory expectations, and compliance in a highly regulated environment
- Ability to lead and influence cross-functional teams and align engineering strategy with business objectives
- Experience in facility planning, asset lifecycle management, and infrastructure strategy
- Technical expertise in facility systems, utilities, and manufacturing equipment within cGMP environments
- Working knowledge of Quality Systems, including deviations, investigations, CAPAs, and change control processes
- Experience managing budgets, capital planning, and cost optimization
- Familiarity with digital and data-driven engineering tools, including predictive maintenance and performance monitoring systems
- Excellent written and verbal communication skills, with the ability to influence stakeholders at all organizational levels
- Ability to lead and develop teams, supporting employee growth and performance
- Strong ability to collaborate effectively with internal teams, contractors, suppliers, and regulatory agencies
- Experience in strategic planning, budgeting, forecasting, and resource allocation
- Prior experience with SAP or similar enterprise systems preferred
- Proficiency in Microsoft Office applications and project management tools (e.g., MS Project)
- Demonstrated ability to manage multiple priorities in a dynamic, fast-paced environment
- Customer-focused and quality-driven, with a commitment to operational excellence and continuous improvement

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.