Quality

Regeneron Pharmaceuticals, Inc.

Senior Manager GD GCP Auditing (Ireland)

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a **Senior Manager GD GCP Auditing** to join our Global Development Quality Assurance team, supporting our global development organization in a remote work model. In this role, you will lead risk-based quality auditing activities and strengthen GCP compliance while collaborating with Global Development teams, external partners, and quality stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Location: Ireland

Work model: Remote

**Discover your role:**

- Lead end-to-end GCP audits across internal and external global activities.
- Schedule, conduct, report, and follow up on routine and directed audits.
- Develop and execute risk-based audit programs for assigned clinical studies.
- Identify compliance issues and drive process improvements and standardization.
- Representing Quality Assurance on complex compliance projects and initiatives.
- Interpret policies, standards, and regulations to address critical issues.
- Support regulatory inspections and inspection room activities.
- You thrive in a dynamic environment and build trusted stakeholder partnerships.

**This role requires:**

- Bachelors degree with 8+ years of relevant industry experience; Masters degree preferred.
- At least 5 years of direct Good Clinical Practice audit experience.
- Expert knowledge of FDA regulations, European Union regulations, ICH guidance, and GCP requirements.
- Experience conducting audit types including process, site, vendor, and partner audits.
- Experience with regulatory inspections involving investigator sites, sponsors, or Contract Research Organizations.
- Ability to independently manage complex GxP compliance issues and high-value priorities.
- Strong leadership skills with experience interfacing with senior leaders.
- Excellent project management, stakeholder management, collaboration, and negotiation skills.
- Strong problem-solving, written, and verbal communication skills.
- Ability to work independently, take initiative, and perform effectively in ambiguous environments.
- High attention to detail, accuracy, and organizational awareness.
- Willingness to travel 30-40% domestically and internationally.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

86,800.00 - 141,200.00

Other Non-US

Senior Manager GD GCP Auditing (UK)

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a **Senior Manager GD GCP Auditing** to join our Global Development Quality Assurance team, supporting our global development organization in a remote work model. In this role, you will lead risk-based quality auditing activities and strengthen GCP compliance while collaborating with Global Development teams, external partners, and quality stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Location: United Kingdom

Work model: Remote

**Discover your role:**

- Lead end-to-end GCP audits across internal and external global activities.
- Schedule, conduct, report, and follow up on routine and directed audits.
- Develop and execute risk-based audit programs for assigned clinical studies.
- Identify compliance issues and drive process improvements and standardization.
- Representing Quality Assurance on complex compliance projects and initiatives.
- Interpret policies, standards, and regulations to address critical issues.
- Support regulatory inspections and inspection room activities.
- You thrive in a dynamic environment and build trusted stakeholder partnerships.

**This role requires:**

- Bachelors degree with 8+ years of relevant industry experience; Masters degree preferred.
- At least 5 years of direct Good Clinical Practice audit experience.
- Expert knowledge of FDA regulations, European Union regulations, ICH guidance, and GCP requirements.
- Experience conducting audit types including process, site, vendor, and partner audits.
- Experience with regulatory inspections involving investigator sites, sponsors, or Contract Research Organizations.
- Ability to independently manage complex GxP compliance issues and high-value priorities.
- Strong leadership skills with experience interfacing with senior leaders.
- Excellent project management, stakeholder management, collaboration, and negotiation skills.
- Strong problem-solving, written, and verbal communication skills.
- Ability to work independently, take initiative, and perform effectively in ambiguous environments.
- High attention to detail, accuracy, and organizational awareness.
- Willingness to travel 30-40% domestically and internationally.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Eli Lilly and Company

QC Environmental Monitoring Technician - Night Shift

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.

**Company 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 39,000 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 Overview:**

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly 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. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

**Position Description:**

Provide support for Parenteral Operations by performing environmental monitoring of the classified manufacturing areas and by performing utility sampling and analysis within the Parenteral Operations and QC Laboratory buildings. The QC Expert Environmental Monitoring Technician will assist the QC Environmental Monitoring management with training other QC Environmental Monitoring Technicians and providing support in the manufacturing areas during routine environmental monitoring and utility sampling.

**Key Objectives/Deliverables:**

- Adhere to and promote compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices.
- Provide support for Parenteral Operations activities by performing environmental monitoring of classified manufacturing areas.
- Provide support for manufacturing and laboratory activities by performing utility sampling and analysis within the Parenteral Operations and QC Laboratory buildings.
- Assist with technical training and mentoring of QC Environmental Monitoring Technicians through formal process/program.
- Participate in department/company continuous improvement projects and initiatives.
- Assist with authoring Standard Operating Procedures and Work Instruction documentation.
- Adhere to and promote compliance of all safety standards.

**Minimum Requirements:**

- Education
  - High School Diploma or equivalent, Associate Degree is preferred.

- Experience
  - 2+ years of demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production.
  - Demonstrated ability in performing environmental monitoring techniques including, but not limited to viable surface monitoring, viable and non-viable air monitoring, compressed air monitoring, and water (potable, purified water, water for injection, clean steam) collection and analysis.
  - Previous experience with Laboratory IT systems such as LIMs, LES, and MODA.

- 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:**

- Experience with cGMP requirements and regulatory compliance associated with a cGMP Manufacturing facility.
- Strong interpersonal skills and ability to train/mentor QC Environmental Monitoring Technicians.
- Strong oral and written communication skills for communicating to colleagues, management, and other departments.
- Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
- Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.

**Other Information:**

- The role will be phased from a project support role to a routine support role as the development facility and processes progress.
- During the project phase the working schedule will vary (typically M-F 8 hours). In operation, must have ability to work 12-hour night shift (2-2-3 structure).
- Travel will be required during the project phase for training and implementation of the Environmental Monitoring Program for the Concord site.
- Tasks may require repetitive motion and standing or walking for long periods of time.
- Tasks may require lifting of up to 30 pounds and may require the ability to pass, push, and pull to execute specific aspects of the job role.

The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.

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

$18.75 - $35.96

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

Associate Director – Facilities, Utilities, Maintenance, Engineering (FUME)

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.

Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply.

**Main Purpose and Objectives of Position:**

The Associate Director for Facilities, Utilities, and Maintenance is responsible for the supervision of maintenance, utilities, and reliability employees that support the daily operations of the LP2 (Lebanon Plant 2) advanced therapies manufacturing facility. This includes supervision and development of employees with the purpose of ensuring that equipment, instruments, utilities, and systems are robustly and reliably maintained for use in the manufacturing of advanced therapies drug products. Additionally, the Engineering Associate Director partners to influence and implement within the engineering organization and across functional disciplines to support the maintenance, utilities, and reliability technical agenda, business plan priorities, and compliance plan objectives.

**Key Responsibilities:**

**Administrative Leadership**

- Supervise and coach engineering and maintenance staff, including completing performance reviews and development plans.
- Staffing including recruiting, resource planning, and succession planning.
- Work coordination across maintenance, reliability, and utilities.
- Review and monitor financial performance, commit to meeting targets.

**Operational Excellence**

- Demonstrate a commitment to environmental, health, and safety.
- Identify, track, and report key indicators of functional performance.
- Ensure team is operating in a state of compliance.
- Develop and implement Maintenance, reliability, and utilities business plan objectives.
- Oversee the development, implementation, and execution of the maintenance program for the facility.
- Remove barriers that impact team performance.

**Organizational Capability**

- In coordination with Global Engineering and other LP2 engineering areas, set and reinforce standards for appropriate rigor in engineering and maintenance work products and utilization of First Principles.
- Assure focus by engineers and completion of critical assignments with appropriate monitoring and reporting.
- Be a fully active member of the flow leadership in running LP2, including participation on management sub-teams.

**Basic Requirements:**

- B.S. in Engineering
- 5+ years of engineering manufacturing-related experience, preferably some biosynthetic drug substance and/or sterile drug product operations and/or maintenance experience
- 2+ years in a leadership position within a manufacturing organization

**Additional Preferences:**

- State licensure as a Professional Engineer is not required but is encouraged.
- Ability to instill teamwork within the department and demonstrate key interpersonal skills.
- Ability to ensure appropriate technical depth and rigor with departmental technical deliverables.
- Successful application of organizational models through recruiting and retention of employees.
- Ability to make decisions independently and to network with others as appropriate.
- Ability to provide innovative solutions to plant, divisional, and corporate issues and leverage ideas from other functional areas.
- Ability to communicate verbally and in writing to various audiences, particularly one-on-one coaching and feedback with direct reports.
- Ability to function in a team environment as a leader and as a member of management teams.

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

$123,000 - $180,400

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

Sanofi US

QA Release

**Job Title**: QA Release

**Location:** Swiftwater, PA

**About the job:**

Your job, as QA Batch review specialist within our Quality Assurance team, will be to ensure product quality through batch release processes to market for the Swiftwater Site.

This role will operate under flexibility to perform the necessary activities to ensure compliance requirements and manufacturing/release schedules are met. This role supports core activities: Preparation & Certification of Working Documents, Quality Review of Batch Records from Swiftwater and CMOs, Batch Disposition from Swiftwater and CMOs, Quality Review of Lot Release Protocols, Compliance and Performance.

**Benefits of working in this role:**

- Be part of an inspiring mission to create life-saving vaccines

- Leading a skilled and motivated team of quality professionals

- The work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus.

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**

**Quality Review of Batch Records**

- Perform final Quality review of completed manufacturing records for completeness and accuracy according to site procedures, cGMP, FDAs 21 CFR, and other applicable health authority regulations.

- Complete all required system transactions associated with the batch record review process.

- Provide data for PDR manufacturing dates and Commodity Verification Sheets to allow further processing of material.

**Disposition of Batches**

- Review Specification Checklist, Certificate of Analysis (and Conformance) to verify all required testing has been performed and all testing meets requirements prior to batch disposition.

- Verify CBER release is received (if applicable) prior to batch disposition.

- Verify the lot is not on hold (i.e., deviations, change controls, Approve for Further Manufacture database, etc.) prior to batch disposition.

- Verify all previous manufacturing steps, including raw materials, are satisfactory prior to final disposition of the batch.

- Complete all required system transactions associated with the batch disposition process.

- Act as delegate to the QA Release Lead to provide approval to ship to external manufacturers, as assigned

**Quality Preparation and Review of Lot Release Protocol (LRP)**

- Prepare and Review working LRP for completeness and accuracy prior to submission to the applicable Health Authority.

- For licensed international products- ensure the batch is in full compliance with the GMP requirements and the specifications in the Marketing Authorization of the importing country.

- Ensure LRP review meets cycle time requirements for product releases and SAP confirmation for completion of activity.

**Preparation of Environmental Monitoring Summary (ESUM)**

- Oversee the ESUM process to ensure timelines and compliance standards are met.

- Take assigned lots and complete ESUM reports by compiling and reviewing data in compliance with area EM procedures, finalizing ESUMS in the electronic ESUM database, and meeting release timelines.

- Serve as the SME and function as a liaison for any assigned focus factory initiatives and participate on teams, communicating issues and identifying solutions to support release timelines.

- Contribute to team objectives and priorities on assigned projects.

**Preparation & Certification of Working Documents**

- Prepare batch records from master documents in the electronic document management system according to procedure

- Ensure right first-time preparation and completion of required documentation via electronic system (SAP and/or FaCT)

- Provide support as required to ensure records are prepared and certified in accordance to the production planning schedule.

- Certified prepared batch records to ensure completeness and accuracy in accordance to procedure.

- Provide metrics in support of +QDCI board meetings.

**Compliance and Performance**

- Meet department safety, quality, productivity, and cost targets and goals in a compliant and timely manner Act as Trainer for Batch Release activities.

- Investigate deviations, as assigned.

- Perform special projects as assigned by FFIP QA Leadership team.

- Continuously reviews PQBR processes, and recommends, develops and implements efficiency and quality enhancements.

- Perform CAPA review and approval as required

- Completion of additional tasks as assigned by Team Lead

**Key Involvement in Decision Making:**

- Prioritize quality and compliance objectives (D)

- Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)

- Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D)

- Review documentation for batch disposition (A)

- Advise on initiatives to promote a quality-focused culture (A)

- Advise on how to present a topic and answer specific questions (A)

**About You**

**Basic Qualifications**

- Bachelor's degree.
- 1+ years of experience in a GMP-controlled pharmaceutical environment (e.g., Quality Assurance, Production, Quality Control or related areas).

**Technical Skills**

- Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards.
- Capability to investigate and resolve issues or deviations related to batch release processes efficiently.
- Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards.
- Strong Computer Literacy (including Microsoft excel, power point, word)

**Soft Skills:**

- Ability to analyze complex data and identify trends, issues, and solutions
- High level of accuracy and attention to detail in all quality assurance activities

- Proficiency in identifying problems and implementing effective corrective actions
- Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
- High level of autonomy

**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

**Job Title** QA Release

**Location:**  Swiftwater, PA

**About the Job**

Your job, as QA Batch review specialist within our Quality Assurance team, will be to ensure product quality through batch release processes to market for the Swiftwater Site.

This role will operate under flexibility to perform the necessary activities to ensure compliance requirements and manufacturing/ release schedules are met. This role supports core activities: Preparation & Certification of Working Documents, Quality Review of Batch Records from Swiftwater and CMOs, Batch Disposition from Swiftwater and CMOs, Quality Review of Lot Release Protocols, Compliance and Performance.

**Benefits of working in this role:**

- Be part of an inspiring mission to create life-saving vaccines

- Leading a skilled and motivated team of quality professionals

- The work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus.

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**

**Quality Review of Batch Records**

- Perform final Quality review of completed manufacturing records for completeness and accuracy according to site procedures, cGMP, FDAs 21 CFR, and other applicable health authority regulations.

- Complete all required system transactions associated with the batch record review process.

- Provide data for PDR manufacturing dates and Commodity Verification Sheets to allow further processing of material.

**Disposition of Batches**

- Review Specification Checklist, Certificate of Analysis (and Conformance) to verify all required testing has been performed and all testing meets requirements prior to batch disposition.

- Verify CBER release is received (if applicable) prior to batch disposition.

- Verify the lot is not on hold (i.e., deviations, change controls, Approve for Further Manufacture database, etc.) prior to batch disposition.

- Verify all previous manufacturing steps, including raw materials, are satisfactory prior to final disposition of the batch.

- Complete all required system transactions associated with the batch disposition process.

- Act as delegate to the QA Release Lead to provide approval to ship to external manufacturers, as assigned

**Quality Preparation and Review of Lot Release Protocol (LRP)**

- Prepare and Review working LRP for completeness and accuracy prior to submission to the applicable Health Authority.

- For licensed international products- ensure the batch is in full compliance with the GMP requirements and the specifications in the Marketing Authorization of the importing country.

- Ensure LRP review meets cycle time requirements for product releases and SAP confirmation for completion of activity.

**Preparation of Environmental Monitoring Summary (ESUM)**

- Oversee the ESUM process to ensure timelines and compliance standards are met.

- Take assigned lots and complete ESUM reports by compiling and reviewing data in compliance with area EM procedures, finalizing ESUMS in the electronic ESUM database, and meeting release timelines.

- Serve as the SME and function as a liaison for any assigned focus factory initiatives and participate on teams, communicating issues and identifying solutions to support release timelines.

- Contribute to team objectives and priorities on assigned projects.

**Preparation & Certification of Working Documents**

- Prepare batch records from master documents in the electronic document management system according to procedure

- Ensure right first time preparation and completion of required documentation via electronic system (SAP and/or FaCT)

- Provide support as required to ensure records are prepared and certified in accordance to the production planning schedule.

- Certified prepared batch records to ensure completeness and accuracy in accordance to procedure.

- Provide metrics in support of +QDCI board meetings.

**Compliance and Performance**

- Meet department safety, quality, productivity, and cost targets and goals in a compliant and timely manner Act as Trainer for Batch Release activities.

- Investigate deviations, as assigned.

- Perform special projects as assigned by FFIP QA Leadership team.

- Continuously reviews PQBR processes, and recommends, develops and implements efficiency and quality enhancements.

- Perform CAPA review and approval as required
- Completion of additional tasks as assigned by team Lead

**Key Involvement in Decision Making:**

- Prioritize quality and compliance objectives (D)

- Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)

- Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D)

- Review documentation for batch disposition (A)

- Advise on initiatives to promote a quality-focused culture (A)

- Advise on how to present a topic and answer specific questions (A)

**About You**

**Basic Qualifications**

- Bachelor's degree.
- 1+ years of experience in a GMP-controlled pharmaceutical environment (e.g., Quality Assurance, Production, Quality Control or related areas).

**Technical Skills**

- Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards.
- Capability to investigate and resolve issues or deviations related to batch release processes efficiently.
- Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards.
- Strong Computer Literacy (including Microsoft excel, power point, word)

**Soft Skills:**

- Ability to analyze complex data and identify trends, issues, and solutions
- High level of accuracy and attention to detail in all quality assurance activities

- Proficiency in identifying problems and implementing effective corrective actions
- Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
- High level of autonomy

**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>)

QA Release Senior Quality Reviewer

**Job Title**: QA Release Senior Quality Reviewer

**Location:** Swiftwater, PA

**About the job:**

This role provides quality oversight of the Batch Release Protocol (BRP) process and final release to market. This role will perform final review and approval of all batch release protocols for both foreign and domestic submissions.

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.

**Benefits of working in this role**:

- Be part of an inspiring mission to create life-saving vaccines
- Leading a skilled and motivated team of quality professionals
- The work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

**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**

- Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements
- Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)
- Reviewing and performing final approval of batch release protocols
- Perform final approval of batch release protocol product configurations
- Coordinate with supply chain and regulatory affairs to schedule batch release protocols and priorities
- Perform ship approval for batches destined for international countries.
- Fostering a culture of quality and continuous improvement across the organization
- Participating in internal and external audits and regulatory inspections providing support and documentation
- Investigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event)
- Collaborating with regulatory affairs to ensure compliance with local and international regulations
- Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness
- Participating in Quality Alert/Product Alert meetings and ensuring that investigation and actions taken during those meetings allow the decision for disposition of lots
- Perform any other tasks assigned by Manager

**Key Involvement in Decision Making:**

- Prioritize quality and compliance objectives (D)
- Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)
- Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D)
- Review and approve documentation for batch disposition (A)
- Release of all stages of batches, focusing on the formulation, master/fill/inspect, and packaged stages
- Advise on initiatives to promote a quality-focused culture (A)
- Advise on how to present a topic and answer specific questions (A)

**About You**

**Basic Qualifications**

- Bachelor's degree.
- 3+ years of experience in Quality Assurance within the pharmaceutical industry.
- Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles

**Technical Skills**

- Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards.
- Capability to investigate and resolve issues or deviations related to batch release processes efficiently.
- Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards.
- Strong Computer Literacy (including Microsoft excel, power point, word)

**Soft Skills:**

- Ability to analyze complex data and identify trends, issues, and solutions
- High level of accuracy and attention to detail in all quality assurance activities

- Proficiency in identifying problems and implementing effective corrective actions
- Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
- High level of autonomy

**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; colour; 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>)

Quality Assurance Validation Engineer

**Job title:** Quality Assurance Validation Engineer

**Location:** Waltham, MA

**About the Job**

**In the race for the future of health The Sanofi mRNA Center of Excellence (CoE)**

At Sanofi, we chase the miracles of science, and we know mRNA has a role to play in the future of health. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines and treatments for more people faster than before.

Thats why were looking for bold, optimistic world-changers to join our mRNA Center of Excellence. Were investing 400M a year into the new Center, hiring a team of 450 dedicated employees, and focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.

Bring your ambition and optimism and join us on our journey to discover and deliver transformative medicine to patients through the advancement of our cutting-edge mRNA technology!

Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, youll help advance prevention on a global scale - and shape the future of immunization.

**About the Opportunity**

The QAV Engineer will support both the Business System Owners and cross-functional technical departments (Validation, Metrology and Automation) at Sanofis mRNA Center of Excellent (CoE) and will report to the Deputy Director, Quality Assurance Validation.This individual will be responsible for supporting all field activities supporting internal and external QA Validation efforts as it pertains to Sanofis mRNA Center of Excellence - at its various internal facilities and CMOs.This individual will be responsible for supporting a team of FTEs and consultants for Validation and Computer Systems Validation efforts at or on behalf of Sanofis mRNA CoE, for QAV related activities.

**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 peoples lives.

**Main Responsibilities**

**Key responsibilities**

- Support and work in partnership with Validation, Automation, Metrology and Quality Control department personnel as well as cross-functionally with sub-QA departments to achieve deliverable and all routine Validation Lifecycle of the relevant Facilities, Utilities, Systems and Equipment and build strong working relationships.
- Provide QA oversight for GMP validation activities and apply risk-based methodology to validation efforts to help drive deliverables on time in a compliant manner, while serving as the QA Validation Subject Matter Expert and interacting with Business System Owners on their needs.
- QAV support on the necessary Project Plans, end to end Validation deliverables and supports any field activities performed in support of their execution.
- Help enforce compliance with senior leadership strategy and direction, as it pertains to the areas of equipment validation, computer systems validation, cleaning validation, Data Integrity initiatives and routine maintenance of validated systems.
- Help author and maintain Standard Operating Procedures incompliant with internal/global standards to support Equipment and Computer System validation for GMP.
- Support the phase appropriate strategy to the validation deliverables for new and existing facilities and labs.
- Provide QA assessment and approval of GMP validated systems related procedures, deviations, CAPAs and change controls with no supervision depending on complexity of system.
- Provide support for additional QAV-related activities during internal audits and self-inspections, supporting documentation, investigations and remediation activities as required.

**Support Sanofis mRNA CoE Metrology and Automation department:**

- Act as the QA contact and QA subject matter expert (SME) on the Metrology and Automation of all equipment/instruments partnering with technical departments and Business System Owners to ensure Data Integrity and cGMP compliance.
- Participate in the continuous improvement and development of Quality Systems to ensure quality and adherence to cGMPs.
- Help investigate and support management in all investigations stemming from Equipment/System failure and determines best course of action for resolution.

**Promote a Quality Culture**

- Support innovation, teamwork and a continuous improvement effort in the level of Quality in Sanofis mRNA CoE documentation.
- Ensure that Sanofis mRNA CoE Validation documentation meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.

**Be accountable for:**

- Implementing the process and tool at local level in line with the standardized and harmonized approach, including communication, change management, etc as appropriate.

**Be responsible for:**

- Being the "Voice of Customer"
- Providing feedback on the roadblocks and difficulties met related to Sanofi Community of Practice (CoP) area supported
- Providing return on experience on inspection assessing the CoP area supported Proposing evolution for simplification and harmonization of the process and tool
- Sharing successes and best practices with other sites
- Contributing to the objectives set via the CoP roadmap

**About you**

- Bachelors degree in mechanical engineering, chemical engineering, computer science, or related fields relevant to the biotech or pharmaceutical industry.
- Minimum 3+ years of experience within a Validation organization in the pharmaceutical, biologics or medical device industries.
- Minimum 3+ years of experience working with facility startups, factory/site acceptance testing, Commissioning/Qualification activities and all associated supporting documentation generated during the course of these activities.
- Experience with continuous improvement of Validation operations in response to business needs and customer audits/regulatory inspections.
- Experience in execution of field activities associated with validation protocols, project plans, data analysis, compilation of data into final reports and project summary/close out.
- Experience in asset management and in NIST traceability to standards.
- Demonstrated experience in working in compliance with US, EU and ICH GMP requirements.
- Preferable experience in early phase clinical efforts, which are not under the stringent requirements of a commercial facility.
- Preferable experience in supporting a Phase I/II company up through commercialization.
- Excellent oral and written communication skills.
- Strong interpersonal skills to effectively manage teams, communicate with peers, management and external contacts.

**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.
- Work at the forefront of AI-driven research, smart manufacturing, and groundbreaking mRNA platforms that are redefining the future of immunology.
- Help protect half a billion people every year, contributing to one of the largest global vaccination efforts in healthcare.
- Develop your career with access to mentoring, international mobility programs, and opportunities to grow across four continents.
- 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 and wellness programs and at least 14 weeks gender-neutral parental leave.

Sanofi US Services 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.

**_As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinatedagainst COVID-19 as part of your job responsibilities._**

\#GD-SP

\#LI-SP

\#LI-Onsite

\#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>)

Massachusetts

Senior Corporate Counsel, Patient Support Services and Diagnostic Testing

**Job Title**: Senior Corporate Counsel, Patient Support Services and Diagnostic Testing

- Location: Morristown, NJ

**About the Job**

We are seeking an experienced attorney with relevant industry experience to join the Sanofi North America Legal team as Senior Corporate Counsel, Patient Support Services & Diagnostic Testing. This role will provide comprehensive legal support to business colleagues at all levels within the commercial operations for Sanofi's Patient Support Services (PSS) and Diagnostic Testing programs.

This role supports both day-to-day operations and long-term strategies, with a focus on securing patient access to Sanofi medicines and supporting Sanofi's product portfolio. The ideal candidate will also have the interest and flexibility to support other parts of the business as needs arise.

Ready to push the limits of whats possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

**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**

*Patient Support Services & Diagnostic Testing:*

- Serve as the primary legal contact for patient support programs and diagnostic testing initiatives, acting as the liaison among business colleagues and all other relevant legal functions (e.g., product support attorneys, market access legal, transversal operations, and compliance)
- Draft, negotiate, and finalize contracts required for implementation of patient support programs (including free drug programs, copay programs, reimbursement services) and diagnostic testing programs
- Advise business partners on the design, launch, and ongoing operation of patient support and diagnostic testing programs, including copay and patient assistance programs, risk mitigation, and customer interactions
- Review external materials for content related to patient support and diagnostic testing programs
- Collaborate with colleagues in the US Privacy Office and Ethics & Business Integrity on relevant privacy and compliance workstreams, act as NA Legal Department representative on relevant privacy workstreams, and coordinate implementation of related initiatives

*Cross-Functional Responsibilities:*

- Work with business colleagues to assist them with adherence to Sanofi's policies and understand legislative, enforcement, and regulatory developments that may impact Sanofi's patient support and diagnostic testing programs
- Ensure client operations comply with applicable laws and company policies, including the Anti-Kickback Statute and other US healthcare compliance laws
- Develop and conduct training for internal teams on compliance and policy development topics
- Analyze initiatives, advisory board proposals, and field-based activities for fraud and abuse, FDA, and other regulatory compliance
- Engage with commercial partners across functions including sales, medical, regulatory, operations, finance, supply chain, manufacturing, pharmacovigilance, and external affairs

**About You**

**Basic Qualifications**

*Education & Experience:*

- JD and a license to practice law in at least one US jurisdiction (New Jersey or Massachusettspreferred)
- Minimum of 7 years of legal experience, preferably including both law firm and in-house experience in the pharmaceutical, biotechnology, or medical device industry
- Experience working in a matrix, international environment

*Professional Knowledge:*

- Substantive working knowledge of US Federal and state laws and regulations relating to the pharmaceutical industry, including the False Claims Act, Anti-Kickback Statute, and competition laws
- Strong understanding of the US healthcare system, including reimbursement and patient access
- Substantive working knowledge of the legal landscape that applies to patient support programs and diagnostic testing
- Experience drafting, interpreting and negotiating contracts with third parties, including vendors supporting patient support and diagnostic testing programs

*Professional Skills:*

- Strong contract drafting and negotiation skills with third parties
- Ability to provide and effectively communicate sound legal advice coupled with a strong understanding of business needs
- Flexibility to manage multiple subject matter issues across diverse areas of the company, taking the initiative to identify appropriate subject matter experts and coordinating overall review
- High degree of organizational skill and attention to detail
- Comfortable engaging in proactive counseling and thoughtful risk-taking
- Ability to be decisive, especially in ambiguous situations
- Demonstrated excellence in understanding complex scenarios, proposing solutions that consider business objectives, and communicating issues clearly
- Sound judgment and commitment to ethical conduct
- Strong interpersonal skills with a solution-oriented approach
- Self-motivated, reliable, responsive, and accountable
- Ability to manage outside counsel effectively and efficiently
- Willingness to adapt job responsibilities and learn new areas as needed, including but not limited to US Market Access and Product Support

**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 and wellness programs and at least 14 weeks gender-neutral parental leave.
- Make your work count by supporting a company that brings life-changing treatments to millions and is committed to doing right by patients, communities, and the planet.
- Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainably
- Support teams across science, medicine, and operations by building better systems, shaping bold strategies, and enabling innovation at speed

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse 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-SA

\#LI-SA

\#vhd

\#LI-Hybrid

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>)

New Jersey

QC Lab Team Supervisor

**Job Title**:QC Lab Team Supervisor

- **Location:** Swiftwater, PA

**About the Job:**

The Quality Control Laboratory Team Supervisor plays a pivotal role in ensuring the highest standards of product quality and patient safety within a pharmaceutical/vaccine manufacturing environment. This position is ideally suited for a seasoned QC laboratory professional who has demonstrated progressive growth through hands-on technician roles, training management, and laboratory management responsibilities. The successful candidate will bring proven expertise in quality control operations, regulatory compliance, and team leadership with a track record of driving continuous improvement while maintaining strict adherence to internal and external GMP requirements.

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:**

**1. Laboratory Operations Management**

- Oversee daily operations of the quality control laboratory to ensure adherence to committed scheduled plans

- Conduct routine shopfloor reviews of the laboratory to identify improvement opportunities

- Ensure accurate and timely testing of received samples according to designated perimeter

- Assist in scheduling laboratory work to meet the demands of production and operational timelines

- Serve as a qualifiedreviewer forkey testing areas to maintain operational continuity and testing coverage, including but not limited to: Wet Chemistry, Electrophoresis, HPLC, LCMS, CCIT, BLFG, ICP, FTIR, GC, MALs, and SEM/EDS.

**2. Compliance & Quality Assurance**

- Maintain the laboratory in compliance with GMPs and quality control processes defined according to internal and external quality requirements and regulations.

- Ensure the use of validated methods within the designated perimeter and execute any validation/transfer protocol as receiving unit.

- Investigate in a timely manner and resolve any quality control events, issues, or discrepancies from the designated perimeter.

- Implement remediation actions from findings and CAPAs (Corrective and Preventive Actions)

- Author and review quality documents as a technical reviewer, including procedure revisions, protocols, reports, change controls, CAPAs, and deviations

- Support internal and external audits through scribing, backroom documentation support, and participation in management walkthroughs for audit preparation and readiness.

- Investigate customer product complaints and conduct deviation investigations, including interpretation and reporting of results

- Assist with logbook creation, certification, logbook review, stability dispensing laboratory operations, and file retention management.

**3.Team Leadership & Development**

- Manage and train laboratory staff, ensuring they follow best practices and safety guidelines

- Ensure laboratory staff is qualified to perform testing execution by maintaining the lab qualification matrix

- Foster a culture of continuous improvement and high performance

- Oversee training compliance

- Actively mentor colleagues to support professional development opportunities

- Participate in the interview and selection process for new hires, including QC production workers, salaried employees, and interns

**4. Technical Operations**

- Maintain laboratory equipment by applying maintenance, qualification, and calibration plans to ensure accuracy and reliability of lab activities

- Ensure lab facilities and instruments are kept in a quality and safety status to ensure appropriate use

- Apply deep, hands-on expertise in specialized techniques including:

- \*\*Particulate Isolation and Characterization\*\* using optical microscopy, photographic analysis, and \*\*Micro-FTIR\*\*

- \*\*FTIR (Fourier Transform InfraredSpectroscopy)\*\* and \*\*SEM/EDS (Scanning Electron Microscopy/Energy DispersiveSpectroscopy)\*\*

- \*\*Container Closure Integrity Testing (CCIT)\*\*

- \*\*BLGF Testing\*\*

- Author technical memorandums and reports

**5. Laboratory & Quality Systems**

- Demonstrate proficiency in laboratory and quality management systems including:
  \*\*Opstrakker,Qualipso,iLearn, SAP, LIMS (LabWare),Trackwise,\*\*and the \*\*Adobe Software Suite\*\*

**About You:**

**Basic qualifications:**

- Bachelors degree in Life Sciences, Pharmaceutical Sciences, Engineering or a related scientific field with at least 8 years of experience in a cGMP environment.

**Experience**

- Progressive QC experience within a pharmaceutical or vaccine manufacturing environment, spanning roles from laboratory technician through training management and laboratory management levels

- Comprehensive knowledge of \*\*Good Manufacturing Practices (GMP)\*\* and regulatory requirements (FDA, EMA, ICH guidelines)

- Direct, hands-on expertise in \*\*Particulate Isolation, Micro-FTIR, and SEM/EDS\*\* analysis within a regulated pharmaceutical environment

- Demonstrated experience authoring and reviewing technical reports, memorandums, and quality documents

- Experience in a regulated compendial testing environment \*(USP/EP/JP standards aplus)\*

- Active involvement in regulatory and internal inspections and audit support activities

**Technical Skills**

- Advanced analytical skills with the ability toanalyzecomplex data and laboratory results to make informed decisions and identify areas for improvement

- Proficiency in identifying issues and implementing effective solutions to resolve quality control problems

- Expert knowledge of laboratory instrumentation, maintenance, qualification, and calibration procedures

- Strong understanding of method validation and transfer protocols

- Proficiency in laboratory information management systems (LIMS) and quality systems (Trackwise, SAP,iLearn, etc.)

- Experience with \*\*continuous improvement and Lean initiatives\*\*, including tracking cost and efficiency metrics, is a differentiating strength \*(e.g., demonstrated revenue/efficiency performance abovetarget)\*

**Leadership & Soft Skills**

- Strong leadership abilities to manage and motivate a team, ensuring high performance and adherence to quality standards

- Excellent written and verbal communication skills

- Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements

- Ability to work effectively under pressure and manage multiple priorities

- Strong problem-solving and critical thinking capabilities

- Commitment to continuous improvement and quality excellence

**Health, Safety & Environment (HSE) Valued Asset**

- Experience serving as an \*\*HSE safety representative or correspondent\*\*, including conducting regular lab area inspections as preventative actions

- Demonstrated experience performing monthly \*\*GEMBA walks\*\* and \*\*Satellite Accumulation Area inspections\*\*

- Experience facilitating safety initiatives, presenting safety communications, and driving action item completion within a QC department

- Ability to provide safety metrics for department-level meetings (L1, L2, QDCI) and serve as backup to the QC HSE manager

- Strong commitment to maintaining a safe laboratory environment as a core operational priority

**Working Conditions**

- Laboratory environment with exposure to chemicals and specialized equipment

- May require the use of personal protective equipment (PPE)

- Standard working hours with flexibility based on operational needs, i.e. overtime may be required

**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 weeksgender-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 militarystatus 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>)

Principal QA Validation Specialist, Fill Finish

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Quality Assurance (QA) Validation Specialist to join our QA Validation team. They will lead the utilities and EMPQ team for our internal fill finish facility, overseeing qualification of utilities, cleanrooms, and filling lines critical to commercial production; ensure regulatory compliance, strengthen the contamination control strategy, and drive key licensure activities.

**When & where:**

- Location: Rensselaer, New York, United States
- Work model: Monday-Friday, 8am-4:30pm

**Discover your role:**

- Lead validation and serve as SME for utilities and environmental qualification; assess change controls, review CAPAs/NOEs, approve documents, and lead audits
- Plan and execute cleanroom qualifications and requalification; oversee EMPQ for filling line clean air equipment
- Drive QRM deliverables including HACCP assessments and continuous trending/reporting
- Lead investigations of contamination events associated with environmental monitoring in cleanrooms and clean air equipment
- Qualify critical utilities: Water for Injection (WFI) , pharmaceutical air, AHUs, clean steam generators, and nitrogen distribution systems
- Manage and develop a specialist and a team of consultants to meet project milestones and deliver qualification/documentation deliverables
- Establish processes that ensure compliance with regulatory requirements, including participation in Annex 1 gap assessments
- Influence the creation and revision of local/global policies, standards, procedures, and business processes to align with industry best practices
- Demonstrated experience in a cGMP-regulated environment, including validation, inspection and audit readiness
- Possesses strong cross-functional collaboration and communication skills

**The environment and physical rhythms of the role:**

- Gowning: Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
- Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

**This role requires:**

- BS/BA in Engineering, Chemistry, or Life Sciences and 8+ years of relevant experience
- Experience in utility and facility qualification/validation

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$92,200.00 - $150,600.00

New York

Senior Quality Assurance Validation Specialist

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sr. QA Validation Specialist to join our Quality Assurance team. As the Senior QA Validation Specialist, you will validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: Rensselaer, New York, United States
- Monday-Friday, 8am-4:30pm

**What youll do:**

- Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Analyzes the results of testing and determines the acceptability of results against pre-determined criteria
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements
- Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions
- Reviews, edits and approves change controls, SOPs, reports and other documentation
- Coordinates with other departments or outside contractors/vendors to complete validation tasks Executed real-world and simulated transport studies, including gross-damage visual inspections, pallet configuration assessments, and qualification of secondary and tertiary packaging materials
- Conducts temperature mapping for controlled environments and distribution lanes
- Programs and deploys instrumentation to capture vibration and shock profiles; analyzed data to inform packaging design and handling recommendations
- Programs humidity and pressure sensors and interpreted datasets to support test plans and root-cause analysis
- Applies ASTM and/or ISTA standards to cold-chain shipping design, testing, and qualification
- Performs small-parcel and palletized-load qualifications, including test planning, execution, and reporting

**Gowning and Environment:**

- Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
- Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

**Lets find out if were a fit:**

- Requires B.S in life sciences or related field; may substitute proven experience for education requirement
  - QA Validation Specialist: 4 + years of experience
  - Sr. QA Validation Specialist: 6+ years of experience
- Level will be determined based on experience

**Thrive today. Grow tomorrow.**

- Student loan paydown program & tuition reimbursement
- Family care benefits
- Relocation assistance
- Inclusion, culture and well-being programs (including physical & mental health)

\#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$67,400.00 - $128,700.00

Director, Data Management Process, Quality & Inspection Readiness

**Build our future together:**

The Director, Data Management Process, Quality, and Inspection Readiness provides strategic leadership for Data Management quality, inspection readiness, and process excellence. This role is accountable for establishing and driving standardized approaches to Data Management quality, process frameworks, governance, compliance, and operational execution while ensuring compliance with global regulatory requirements, GCP, and industry best practices. The position serves as the primary Data Management lead for health authority inspections and audits, accountable for inspection preparation, response coordination, functional representation, and ensuring teams are prepared to effectively represent the function during regulatory inspections. In addition, the role also owns and drives the development, governance, and continuous improvement of Data Management processes, training programs, and operational frameworks to support standardized, scalable, compliant, and inspection-ready execution across the Data Management organization.

**When & where:**

- Work Location: Warren, NJ, Tarrytown, NY or Armonk, NY
- 4 days per week on site
- 25% Travel may be required

**Discover your role:**

*Data Management Quality and Inspection Readiness*

- Provide strategic leadership for Data Management quality and compliance, ensuring consistent application of quality standards and resolution of complex and systemic issues.
- Develop Data Management quality frameworks, including CRO oversight, issue management, escalation pathways, and quality oversight processes to support proactive identification and management of operational quality issues and compliance gaps.
- Ensure Data Management quality frameworks and operational activities are aligned with GCP, ICH guidelines, global regulatory requirements, and company quality standards.
- Lead quality event and CAPA management activities, including root cause analysis, and implementation of sustainable corrective and preventive actions. Leverage insights to strengthen controls, improve processes, and enhance inspection readiness.
- Collaborate with CRO partners and internal stakeholders on quality events, issue escalation, remediation activities, and CAPA implementation.
- Lead Data Management inspection readiness and audit support; direct preparation, coordination, and response for health authority inspections.
- Lead and conduct independent, risk-based reviews of study documentation and operational conduct at defined and ad hoc timepoints to identify gaps, strengthen compliance, and ensure sustained inspection readiness.
- Establish Data Management quality review processes to identify process gaps and deficiencies, training needs, and the documentation of risks, enabling early remediation.
- Establish and leverage Data Management KPI & KQI frameworks to provide visibility into performance, data quality, & compliance trends, driving proactive decision-making, continuous improvement, & innovation across the portfolio.
- Define, monitor, and perform effectiveness checks measures for Data Management quality, compliance, inspection readiness, training and process performance to drive continuous improvement and operational excellence.
- Lead impact assessments for new and evolving regulatory requirements, ensuring appropriate updates to Data Management processes, quality standards, and operational practices.
- Educate and guide the Data Management organization on quality standards, regulatory expectations, and inspection readiness practices.
- Establish and maintain strong partnerships with Inspection Management and Quality stakeholders to ensure alignment on inspection readiness activities, quality standards, compliance expectations, and remediation strategies.
- Oversee Data Management SharePoint repositories to support centralized access to current quality and inspection readiness documentation.

*Data Management Process and Training*

- Own and drive the development, governance, and continuous improvement of Data Management processes to support scalable, standardized, compliant, and inspection-ready execution.
- Develop and execute robust implementation and change management plans for new and revised Data Management processes to ensure consistent adoption, operational effectiveness, and sustainable execution.
- Establish & maintain training frameworks to support consistent implementation through development, maintenance, and delivery of role-based training and guidance.
- Lead the Data Management SME network to ensure designated subject matter expertise, process ownership, and functional support coverage across Data Management.
- Oversee Data Management SharePoint repositories to support centralized access to current process and training documentation.
- Serve as a Data Management representative in the Global Development Process Owner Network.
- Establish and maintain strong partnerships with the Process & Procedures, Learning Center of Excellence, Change Management functions to ensure alignment on Data Management processes and training.
- Lead and contribute to cross-functional process improvement initiatives as required.

*People Management*

- Responsible for line management and performance of direct reports, including the development of competencies, coaching, and assessment of annual performance.
- Provide leadership, mentorship, and guidance to direct reports, fostering skill development, knowledge sharing, and operational excellence.
- Foster a culture of accountability, collaboration, continuous improvement, and quality.
- Support prioritization and workload management to ensure effective utilization.

**This role requires:**

- Minimum Bachelor's Degree (Science, Health, Computing, or related field) with 12+ years in Clinical Data Management within the biotechnology, pharmaceutical or health related industry.
- 5+ years of people management, leadership, and mentoring
- Expert knowledge of clinical data management principles, processes, quality frameworks, and inspection readiness practices within a global clinical development environment.
- Deep understanding of global regulatory requirements and industry standards, including GCP, ICH guidelines, 21 CFR Part 11, ALCOA+ principles and inspection readiness expectations.
- Demonstrated experience leading Data Management quality, compliance, inspection readiness, audit support and process governance activities.
- Demonstrated experience developing, implementing, and continuously improving departmental processes, quality standards and frameworks, and operational controls.
- Strong knowledge of quality management systems, CAPA processes, issue management, escalation frameworks, and continuous improvement methodologies.
- Demonstrated experience supporting multiple health authority inspections across different health authorities (e.g., FDA, PMDA, MHRA, EMA, etc..) including inspection preparation, response coordination, remediation activities, and functional representation during regulatory inspections.
- Experience establishing and leveraging KQI / KPI frameworks, effectiveness measures, and operational metrics to drive quality oversight, compliance monitoring, and process improvement.
- Demonstrated ability to lead organizational change management initiatives, including implementation of new processes, quality standards, and operational frameworks.
- Demonstrated success in solving complex business problems through strategic and critical thinking.
- Proven ability to lead and influence within a matrix organization, driving alignment and outcomes with cross-functional stakeholders without direct authority
- Proven ability to build strong collaborative relationships and influence alignment across key internal and external stakeholders.
- Strong understanding of cross-functional activities and management of multiple and varied tasks with enthusiasm and attention to detail.
- Excellent interpersonal, oral, and written communication skills.
- Demonstrated ability to effectively lead and prioritize within a fast-paced, evolving, and highly regulated environment.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$183,100.00 - $305,200.00

Principal QA Specialist

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a **Principal QA Specialist** to join our **QA Compliance & Quality Systems** team.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**Where:**

- Location: Raheen, Limerick

**What youll do:**

- Serving as a Quality Systems Subject Matter Expert (SME) with primary responsibility for Change Control governance, oversight, and continuous improvement activities.
- Providing quality and compliance oversight of Quality System processes, including but not limited to: Change Control, Deviations, CAPA's, Audits, Customer Complaints and Risk Management.
- Ensuring Quality System records are managed in compliance with regulatory requirements, company procedures, and data integrity expectations.
- Reviewing and approving Quality System documentation, including Change Control records, Deviation investigations, CAPA plans and Risk assessments.
- Leading or supporting governance forums, review boards, and cross-functional meetings associated with Change Control and Quality System management.
- Monitoring, analysing, and communicating Quality System performance metrics and trends, finding opportunities to improve process effectiveness, efficiency, and compliance.
- Performing quality review of complex, high-impact, and cross-functional changes to ensure appropriate assessment of product quality, regulatory, validation, and operational impacts.
- Supporting regulatory inspections and customer audits, including preparation activities, presentation of Quality System processes, and response development for observations or commitments.
- Identifying compliance risks, process gaps, and systemic issues within Quality Systems and leads or supports development and implementation of sustainable corrective actions.
- Collaborating with Manufacturing, Quality Control, Engineering, MSAT, Supply Chain, Validation, Regulatory Affairs, and other site functions to ensure quality and compliance requirements are effectively integrated into business processes.
- Leading and participating in continuous improvement initiatives aimed at enhancing Quality System performance, inspection readiness, and operational excellence.
- Supporting the development, implementation, and maintenance of Quality System procedures, policies, and training programs.

**The environment and physical rhythms of this role:**

- Experience working with Quality Systems, including one or more of the following: Change Controls, Deviations, CAPA's, Audit Management and Risk Management
- Working knowledge of cGMP requirements and regulatory expectations.
- Strong organisational, communication, and stakeholder management skills, with the ability to effectively coordinate activities across multiple functional areas.
- Able to prioritise, re-prioritise as needed and adapt to change.
- Comfortable working in a fast-paced setting.

**Lets find out if were a fit:**

- Requires BSc/BEng in scientific discipline or related field with 7+ years of relevant work experience in pharmaceutical or related industry.

**Thrive today. Grow tomorrow.**

**#IRELIM #JOBSIEST #LI-Onsite #REGNQA**

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

63,200.00 - 103,200.00

Senior QA Validation Specialist

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a **Senior QA Validation Specialist** to join our **Quality Assurance** team.

This position offers the opportunity to contribute to a fast-growing, science-driven organisation making a meaningful difference to patients worldwide.

**Where:**

- Location: Raheen, Limerick
- Some travel may be required.

**What youll do:**

- Generating, executing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Analysing the results of testing and determines the acceptability of results against pre-determined criteria
- Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements
- Reviewing, editing and approval deviation notifications, deviation investigations, and corrective actions
- Reviewing and approval of change controls, SOPs, reports and other documentation
- Coordinating with other departments or outside contractors/vendors to complete validation tasks
- Managing projects and prepares status reports
- Providing oversight to contingent workers may be a requirement

**The environment and physical rhythms of this role:**

- Ability to work independently or as part of a team
- Ability to communicate with transparency
- Meets commitments on scope and on time
- Follows directions, performs well-defined tasks
- Effective time management skills

**Lets find out if were a fit:**

- To be considered for this opportunity you must have a BS/BA in Engineering, Chemistry or Life Science and requires at least 5 8+ years proven experience in Commissioning / Qualification experience with Large Scale Process equipment

**Thrive today. Grow tomorrow.**

**#IRELIM #JOBSIEST #LI-Onsite #REGNIEQA #REGNQA**

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

54,200.00 - 88,400.00

Sr QA Validation Specialist

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a **Senior QA Validation Specialist** to join our **Quality Assurance** team.

This position offers the opportunity to contribute to a fast-growing, science-driven organisation making a meaningful difference to patients worldwide.

**Where:**

- Location: Raheen, Limerick
- Some travel may be required.

**What youll do:**

- Supervising the end-to-end qualification process ensuring each piece of equipment fits for the intended use that contribute to 365 inspection readiness program
- Following, fostering and implementing a quality culture and other company manufacturing standards, policies and procedures
- Scheduling, executing, reviewing and approving qualification activities
- Assessing executed change controls and deviations for impact to the qualified state for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria
- Investigating and troubleshooting problems which occur and determining solutions or recommendations for changes and/or improvements
- Reviewing, editing, and approving deviation notifications, deviation investigations and corrective actions, change controls, SOPs, reports and other documentation
- Coordinating with other departments and outside contractors/vendors to complete validation tasks
- Managing and driving projects
- Supervising, providing direction and assigning work to less experienced full-time employees (e.g. validation specialists) and/or contingent workers to meet goals and deadlines

**The environment and physical rhythms of this role:**

- Ability to work independently or as part of a team
- Strong knowledge and understanding of the equipment used for QC analysis and operations
- Ability to communicate with transparency
- Meets commitments on scope and on time
- You have strong knowledge of Data Integrity
- Ability to prioritize and balance multiple tasks simultaneously
- You have project management experience

**Lets find out if were a fit:**

- To be considered for this opportunity you must have a BS/BA in Engineering, Chemistry or Life Science and requires at least 5 8+ years proven experience within the field preferred; may substitute relevant experience for education.
- Previous experience as a SME in a highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory audits
- Strong background in site change controls, risk management and data integrity initiatives/programs
- You have expert knowledge of EU annex 11 and FDA 21 CFR Part 11

**Thrive today. Grow tomorrow.**

**#IRELIM #JOBSIEST #LI-Onsite #REGNIEQA #REGNQA**

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

54,200.00 - 88,400.00

Principal Quality Assurance Reviewer

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Quality Assurance (QA) Specialist/Reviewer to support our Fill Finish facility. In this role, you will perform all compliance related tasks necessary to review and approve investigations and provide quality oversight to the implementation of robust corrective actions for supporting manufacturing operations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: Rensselaer, New York, United States
- Work model: Monday-Friday, 8am-4:30pm

**Discover your role:**

- Independently reviews and approves:
  - Investigations into non-conformances and proposed actions to prevent reoccurrences in support of manufacturing operations
  - Laboratory investigations into out of specification (OOS) and out of trend ( OOT) results
  - Supplier corrective action requests and proposed vendor actions
- Coaches investigation team to enable preparation of investigation reports that include recommendations on investigation findings for medium/high severity non-conformances
- Analyzes and evaluates information captured through investigations, summarizes information and trends in investigation reports
- Presents quality considerations and recommendations at group meetings with multiple levels of management
- Reviews primary data sources to assure the accuracy of investigative conclusions in accordance with cGMP standards in support of investigations
- Provides quality reviews and oversight on a wide range of investigations of differing subject matter
- Monitors production processes and quality systems data to acquire vital data in support of investigations and track efficiency of changes
- Participates in and/or leads cross-functional study teams to get results
- Captures, trends and analyzes process related data to drive consistency and timeliness
- Trains employees on investigative processes and techniques
- Coordinates and/or leads cross-functional meetings with multiple departments

**This role requires:**

- BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience
  - Principal QA Specialist: 8+ years of relevant experience
  - Staff QA Specialist: 10+ years of relevant experience
  - Level will be determined based on experience
- Experience with sterile drug product manufacturing, fill finish and/or quality control testing

\#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$92,200.00 - $176,000.00

Quality Assurance Specialist, On the floor (Overnights)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Quality Assurance (QA) Specialist to join our QA Drug Product team. This position will support QA initiatives for a broad range of topics relative to the start-up and operations of a drug product facility. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: East Greenbush, New York, United States
- Work model, available shifts:
  - 3rd shift, Friday-Tuesday, 10pm-8:30am
  - 3rd shift, Monday-Friday, 10pm-8:30am

**What youll do:**

- Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team
- Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures
- Develop, write, review, and approve SOPs, specifications, and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.
- Maintain project timelines to support the evolving business
- Perform on-the-floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents
- Review and approval of documents (electronic and paper-based)
- Provide mentorship during on-the-floor manufacturing
- Support audits, inspections and investigations
- Perform quarantine, segregation of material and line clearances
- Contribute to the continuous improvement initiatives
- Adjust schedule based on facility start up, filling, and manufacturing needs
- Collaborate with cross-functional internal teams

**The environment and physical rhythms of this role:**

- Gowning: full cleanroom attire (examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
- Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
- Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
- Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

**Lets find out if were a fit:**

- Requires B.S in life sciences or related field; may substitute proven experience for education requirement
  - Assoc QA Specialist : 2+ years of experience
  - QA Specialist : 4 + years of experience

Level will be determined based on experience

**Thrive today. Grow tomorrow.**

- Student loan paydown program & tuition reimbursement
- Family Care Benefits
- Relocation assistance
- Inclusion, culture and well-being programs (including physical & mental health)

\#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$62,355.00 - $110,000.00

Senior Quality Assurance Specialist, On the floor (Overnights)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Senior Quality Assurance (QA) Specialist to join our QA Drug Product team. This position will support QA initiatives for a broad range of topics relative to the start-up and operations of a drug product facility. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: East Greenbush, New York, United States
- Work model: 3rd shift, Friday-Tuesday, 10pm-8:30am

**What youll do:**

- Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team
- Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures
- Develop, write, review, and approve SOPs, specifications, and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.
- Maintain project timelines to support the evolving business
- Perform on-the-floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents
- Review and approval of documents (electronic and paper-based)
- Provide mentorship during on-the-floor manufacturing
- Support audits, inspections and investigations
- Perform quarantine, segregation of material and line clearances
- Contribute to the continuous improvement initiatives
- Adjust schedule based on facility start up, filling, and manufacturing needs
- Collaborate with cross-functional internal teams

**The environment and physical rhythms of this role:**

- Gowning: full cleanroom attire (examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
- Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
- Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
- Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

**Lets find out if were a fit:**

- Requires B.S in life sciences or related field and 6+ years of experience; may substitute proven experience for education requirement
- Level will be determined based on experience

**Thrive today. Grow tomorrow.**

- Student loan paydown program & tuition reimbursement
- Family Care Benefits
- Relocation assistance
- Inclusion, culture and well-being programs (including physical & mental health)

\#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

$78,700.00 - $128,700.00

Supervisor Quality Control (Microbiology)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a **Supervisor, Quality Control** to join our **Quality Control (QC)**  team.

This position offers the opportunity to lead a team of quality control professionals supporting the manufacture and release of biopharmaceutical products for patients worldwide.

**When & Where:**

- **Location:**  Raheen, Limerick, Ireland
- This is an onsite leadership role supporting Quality Control laboratory operations
- The role involves supervising daily laboratory activities and supporting cross-functional business objectives

**What You'll Do:**

- Lead and supervise QC personnel, allocating workload and monitoring team performance
- Ensure laboratory activities comply with cGMP requirements, SOPs, and quality standards
- Support investigations, troubleshooting activities, audits, and continuous improvement initiatives
- Oversee documentation including SOPs, methods, protocols, reports, and training records
- Manage employee development activities including scheduling, performance reviews, coaching, and training compliance

**The Environment and Physical Rhythms of This Role:**

- Thrive in a fast-paced, GMP-regulated laboratory environment
- Balance leadership responsibilities with operational priorities while maintaining a strong focus on quality and safety
- Collaborate with cross-functional teams to support manufacturing and quality objectives
- Foster a culture of continuous improvement, accountability, and employee development

**Let's Find Out if We're a Fit:**

- Requires a BS/BA in Life Sciences or a related field; an MS degree is preferred
- Requires 5+ years of relevant experience within the pharmaceutical, biotechnology, or related industry
- Previous supervisory or people leadership experience is required
- Experience working in a GMP-regulated environment with strong communication and problem-solving skills

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit [https://careers.regeneron.com/en/working-at-regeneron/total-rewards/](<https://careers.regeneron.com/en/working-at-regeneron/total-rewards/>). For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

**Salary Range (annually)**

54,200.00 - 103,200.00