Quality

Regeneron Pharmaceuticals, Inc.

Director, GPS Quality & Compliance

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Our Global Patient Safety (GPS) organization is seeking a Director, GPS Quality & Compliance to support our quality event management and inspection readiness programs. This role partners closely with the Senior Director, GPS leadership, Global Development Quality, and the QPPV Office, and operates as a functional leader who coordinates and delegates work across the team to ensure consistent, high-quality program delivery.

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

**When & where:**

Location: Warren, NJ (preferred), Armonk or Tarrytown, NY, or Cambridge, MA

Work model: 4 days/week on-site

Travel percentage: 20% with some fluctuation expected based on onsite audit/inspection support needs.

**Discover your role:**

Lead functional workstreams across quality event management and inspection programs, coordinating and delegating work across a team

Serve as a trusted point of contact during GCP and GVP audits and inspections, guiding teams through preparation and real-time response

Bring order to complexity by maintaining inspection readiness materials and translating regulatory frameworks into practical action

Champion a culture of accountability and continuous improvement, acting as an escalation point when issues arise

Turn data into direction, reviewing quality metrics and trend analyses to shape clear, actionable recommendations for senior leadership

Communicate with confidence and clarity, presenting governance topics and quality insights to senior team members

Lead through influence, coordinating across teams and functions regardless of formal reporting lines

**This role requires:**

A Bachelor's degree required; advanced degree preferred with a minimum of 12 years of pharmaceutical industry experience; Healthcare Professional background preferred

Deep knowledge of global PV regulations, quality management systems, and inspection readiness frameworks (FDA CFR, GVP Modules)

Demonstrated experience facilitating FDA and EMA/MHRA inspections (GCP and GVP), including direct experience as an inspection point of contact

Proven track record overseeing QMP governance, metrics programs, and cross-functional quality oversight

Experience managing relationships across GDQ, QPPV Office, Regulatory Affairs, and vendors

People management experience preferred

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

New Jersey

Senior Manager GCP Quality

**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, GCP Quality Management - Global Development to join our Global Development Quality team, supporting our global clinical development organisation in a hybrid work model. In this role, you will lead risk-based quality management across clinical trials while collaborating with study teams, clinical functions, contract research organisations, and quality colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Multiple locations are being considered for this role (Hybrid)

**Discover your role:**

- Lead risk-based quality management across assigned clinical trials
- Drive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3
- Manage quality issues, audit responses, corrective actions, preventive actions, and trend analysis
- Partner with study leads, monitoring teams, and contract research organisations on site risks
- Escalate significant quality events and trends to Executive Quality Leadership
- Support inspection readiness, responses, and follow-up actions across relevant functions
- Manage onboarding, development goals, coaching, performance discussions, and team administration
- You champion quality, integrity, continuous learning, and trusted partnerships

**This role requires:**

- Bachelors degree and eight years relevant healthcare or pharmaceutical industry experience
- Quality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice experience
- Advanced risk-based quality management, risk assessment, and compliance knowledge
- Experience managing complex issues, regulatory inspections, and inspection readiness
- Subject matter expert, process owner, training, presentation, and staff management experience
- Process improvement, project management, prioritisation, and time management skills
- Advanced Microsoft Outlook, Word, Excel, and PowerPoint skills
- Strong communication, collaboration

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

Manager Quality Assurance (On the floor)

**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 Manager to join our Quality Assurance (QA) on the floor team. This operational position is responsible for the leadership, development, and oversight of the QA team supporting visual Inspection, assembly, labeling, and packaging operations performed at Regenerons internal Fill/Finish facility.

**When & where:**

- Location: East Greenbush, New York, United States
- Work model, available shifts:
  - Monday-Friday, 8am-4:30pm
  - Monday-Friday, 2-10:30pm

**Discover your role:**

- Manage direct reports, including performance management
- Provide first response for quality and compliance issues encountered on the manufacturing floor
- Lead, set expectations, schedule, and monitor performance standards and goals of assigned team(s) to ensure optimal performance.
- Ensure teams possess the required skills and knowledge, and are appropriately trained, to support plant operations
- Ensure compliance with all regulatory requirements and good documentation practices to provide a safe, quality, and effective product
- Represent Quality function and speak to area processes and responsibilities in regulatory inspections
- Monitor and update area procedures to ensure alignment with policies and operational requirements to ensure quality standards are maintained
- Represent Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
- Review, edit, or approve Regeneron controlled documents; may review or approve master batch records in electronic execution system
- Influence standards, challenge the status quo, and influence others to achieve results
- May oversee and administer visual inspection training and qualification programs

**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 Life Sciences or related field; or equivalent combination of education and experience
  - Associate Manager QA: 6+ years of relevant experience
  - Manager QA 7+ years of relevant experience
  - Level will be determined based on experience
- Previous people leadership/supervisory experience
- Knowledge of visual inspection, assembly, labeling, and packaging operations is preferred

\#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

New York

Director, Integrated Data Review & Quality

**Build our future together:**

The Director, Integrated Data Review provides strategic leadership for the development, implementation, and continuous improvement of integrated data review processes across clinical programs. In partnership with Biostatistics and cross-functional collaborators, this role establishes scalable frameworks, standards, and oversight models to enable proactive, risk-based identification of data issues and ensure high-quality, inspection-ready clinical data. The position drives consistent execution of Data Review Plans and promotes adoption of integrated data review practices across study teams.

**When & where:**

- Location: Warren NJ, Armonk NY, and TarryTown NY
- Work model/flexibility: on site 4 days a week
- Travel percentage: 10%

**Discover your role:**

- Define and lead the Integrated Data Review (IDR) strategy, including the implementation of an appropriate operating model, and governance framework across the portfolio.
- Accountable for consistent execution, oversight, and critical issue of Data Review Plans (DRPs), and proactive identification of data quality risks.
- Define minimum requirements and develop standardized data review plans methodologies, templates, processes, and guidance to enable consistent and effective execution across study teams.
- Provide oversight of data review plans execution through established governance processes, KPIs, and quality metrics to ensure consistency, effectiveness, adherence to standards, and continuous improvement across programs.
- Partner with the Clinical Data Reporting group to develop, implement, and maintain standardized libraries of data review outputs, including visualizations, listings, dashboards, and patient profiles, that support scalable and consistent execution of integrated data review processes across programs.
- Collaborate with Quantitative Innovation and Statistical Strategy (QISS) team to translate Risk-Based Data Management (RBDM) methodologies into practical data review approaches and study-level requirements.
- Proactively identify potential risks to data quality, integrity, and delivery timelines and implement mitigation strategies to ensure continuity, compliance, and successful delivery of departmental objectives.
- Drive continuous improvement and innovation in IDR methodologies and technologies through analysis of metrics, lessons learned, inspection observations, and evolving industry practices.
- Develop and maintain SOPs, work instructions, templates, and training materials using quality-by-design principles to support integrated data review processes.
- Lead implementation, change management, and training initiatives to ensure consistent adoption.
- Drive adoption of IDR methodologies across clinical and external data domains to support proactive issue detection and improved data quality outcomes.
- Liaise with internal and external collaborators to develop strong relationships and ensure effective cross-functional collaboration and communication with respect to deliverables and throughout drug development process.

**This role requires:**

- 12+ years in Clinical Data Management within within the biotechnology, pharmaceutical or health related industry. With 5+ years of people management, leadership, and mentoring
- Expert knowledge of clinical data management principles, processes, technologies and industry best practices.
- Expert knowledge of integrated data review principles, data quality management, and critical-to-quality concepts.
- Deep understanding of regulatory requirements and industry standards, including ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and global data privacy regulations, with the ability to apply these in an operational setting.
- Working knowledge of RBDM principles and their application to Integrated Data Review, including centralized monitoring activities.
- Understanding of Risked Based Quality Management (RBQM) principles and their relationship to integrated data review and centralized monitoring.
- Demonstrated experience establishing, implementing, and evolving integrated data review frameworks, governance models, and methodologies across clinical programs.
- Experience identifying critical data and defining risk-based data review strategies.
- Experience interpreting and analyzing clinical, operational, and external data to identify data trends and potential quality issues.
- Experience developing, implementing, and overseeing Data Review Plans and associated governance processes.
- Demonstrated ability to partner with cross-functional collaborators to support risk-based and integrated data review approaches.
- Understanding of KPIs and quality metrics used to assess effectiveness and impact of integrated data review activities.
- 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 across cross-functional stakeholders without direct authority.

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

Supervisor Quality Control Microbiology

We are currently looking to fill a 2nd shift Quality Control Supervisor focused in Microbiology. Our Quality Control Microbiology Department is responsible for activities related to pharmaceutical microbiology including environmental, personnel and utility monitoring, raw material, in-process, and product release testing. This position will be responsible for ensuring daily operations are completed accurately, timely, and reliably to ensure our medicines are safe and effective before reaching patients around the world. This is an excellent opportunity to join a select group of colleagues while working on molecules that help improve patients lives.

**When & Where:**

- 2nd shift Tuesday- Saturday, 2 PM - 10:30 PM
- Location: Rensselaer, New York, United States

**Discover your role:**

- Coordinate testing and monitoring activities within the QC lab and manufacturing facility.
- Review test results, procedures, protocols, and quality system records.
- Attend cross-functional meetings to remain informed of business needs.
- Organize lab investigations and assay troubleshooting as needed.
- Support internal and regulatory audits.
- Ensure safety and current Good Manufacturing Practice standards are maintained.
- Execute personnel management functions including performance evaluations, personnel development, and scheduling time off.
- Communicate effectively with management on complex matters; support laboratory management in mid to long range team goals.
- Drive and manage projects within the group.
- Coach team members in troubleshooting microbiology methods, Environmental Monitoring, aseptic techniques and equipment.

**This role requires:**

- A BS/BA in Life Sciences or related field, with 5+ years of progressive, relevant experience, preferably within pharmaceutical microbiology.
- Must be able to work **2nd shift Tuesday- Saturday, 2 PM - 10:30 PM**
- Supervisory/leadership experience required.

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

Senior Manager Quality, Internal Audit

**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 to join our Quality Assurance internal auditing team. They are responsible for providing professional expertise, leadership, oversight and assisting with strategic planning for the Regeneron Industrial Operations and Product Supply (IOPS) Quality Auditing function. Quality (GMP) Auditing is responsible for managing the internal audit programs and performing internal audits for Regeneron IOPS, with primary emphasis on GMP, IT and Quality audits that may impact GMP operations and/or products. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

- Location: Troy, New York, United States
- Work model: Monday-Friday, 8am-4:30pm
- Travel percentage: 25-30% domestic & occasionally international

**Discover your role:**

- Maintain up-to-date expertise in global GxP regulations and standards (Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc ) and internal policies; track and communicate industry trends, agency expectations, and warning letters
- Lead enterprise audit programs (internal and external) across GMP, IT, and quality: set strategy, build schedules, plan, assign, and personally lead/participate in audits; ensure inspection readiness
- Manage cross-functional and supplier relationships (procurement, manufacturing, quality, external manufacturing, quality assurance, operations, audit clients) to meet audit schedules, quality deliverables, and organizational goals
- Provide leadership and subject-matter guidance to auditors; recruit, select, train, and assess external proxy auditors; coach, mentor, and develop internal GMP auditing staff; maintain robust training and qualification programs
- Ensure auditing processes meet regulatory and industry requirements; carry out adherence to procedures; document and assess deviations and changes per IOPS processes; uphold safety and operational standards
- Develop, maintain, and present metrics and targets (including RTO) to senior leadership to measure strategy execution and the health of quality auditing systems
- Drive continuous improvement by periodically reassessing auditing processes; translate ambiguity into actionable plans; proactively solve problems to prevent deviations and operational issues
- Accountable for team performance and outcomes of internal/external audit programs, including managing leaders where applicable; support inspections as needed

**This role requires:**

- BS/BA in Life Sciences; or equivalent combination of education and 8+ years of relevant experience
- Experience with quality systems and auditing
- Previous leadership/supervisory experience

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)**

$126,300.00 - $206,100.00

Process Maintenance Technician (Nights)

**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 Process Technician to join our manufacturing operations team, supporting biopharmaceutical production onsite. In this role, you will keep manufacturing, utility, and building systems running safely and in strict cGMP compliance. You will work closely with Facilities Management and cross-functional teams. 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
- Working shift: Sunday-Wednesday 2:00pm-12:30am

- Training shift: Monday-Friday 6:00am-2:30pm
- On-call: Rotational on-call support required

**What youll do:**

- Perform daily operations, maintenance, and repairs on utility systems, manufacturing equipment, and building systems in a cGMP environment.

- Ensure safe, hands-on maintenance of plant manufacturing and support equipment.

- Identify off-nominal conditions and troubleshoot mechanical issues on manufacturing and utility equipment in a clean room environment.

- Complete daily Work Orders and Preventive Maintenance, coordinating workflow and documentation.

- Troubleshoot electrical equipment during off-nominal conditions, locating faults and performing repairs.

- Coordinate with Facilities Management and other departments during planned and unplanned work events.

- Bring a safety-minded focus and a drive for continuous improvement to everything you do.

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

- 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 lift, push, and pull up to 50 pounds

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

- AAS degree, preferably in Engineering or Construction Technologies with the following minimum years of related equipment maintenance experience for each level:
  - Process Technician II: 2+ years or HSD/GED with 5+ years of related experience
  - Process Technician III: 5+ years or HSD/GED with 8+ years of related experience

- Ability to interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications.

- Prior experience in equipment maintenance or a related role requiring mechanical skills.

- Ability to fully gown and work on the production floor.

- Commitment to compliance with regulatory, corporate, and site-specific policies and procedures.

Level will be determined based on qualifications relevant to the role

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 (hourly)**

$24.76 - $44.42

Temp - QA Specialist

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a **Temp QA Specialist** to join our **QA Operations Batch Review** team.

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

**When & where:**

- Location: Raheen, Limerick

**What youll do:**

- Providing QA oversight and support for manufacturing operations, serving as the primary quality representative within production areas
- Partnering with cross-functional teams to facilitate issue resolution, including troubleshooting equipment, process, and schedule disruptions, while ensuring appropriate documentation and quality oversight
- Assessing and triaging potential non-conformances in real time, ensuring required information and documentation are secured to support investigations
- Reviewing and approving documentation associated with routine and non-routine manufacturing activities, including area clearances, incursions, changeovers, and other operational events
- Participating in shift meetings and operational discussions, providing quality mentorship, observations, and recommendations related to ongoing activities and containment actions
- Providing quality consultation and guidance in alignment with QA policies, procedures, and regulatory expectations
- Representing Quality Assurance in the management of complex deviations, change controls, CAPAs, and other quality systems, including active participation in investigations, root cause analysis, and corrective action implementation
- Supporting employee development through training, coaching, and mentoring on QA processes, procedures, and standards
- Performing activities related to product disposition and release, including review of manufacturing records and supporting documentation
- Reviewing and approving investigations associated with product, process, and manufacturing events
- Identifying opportunities for continuous improvement and support initiatives that improve product quality, compliance, and operational efficiency

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

- Excellent organisational skills and attention to detail
- You have the ability to learn and utilise computerised systems for daily performance of tasks
- Strong written, verbal and interpersonal communication skills and can optimally interact cross functionally
- You have the ability to prioritise, manage multiple tasks, and meet deadlines

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

- **Assoc Specialist** - BS/BA in scientific discipline or related field or equivalent combination of education and experience
- **Specialist** - BS/BA in scientific discipline or related field with min 3 years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience
- **Sr Specialist** - BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience

Thrive today. Grow tomorrow.

\#IRELIM #JOBSIEST #LI-Onsite #REGNIRLQA #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.

Specialist - Data Quality & Governance

**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 Data Quality & Governance Specialist Snowflake Data Operations to join our Data Governance team, supporting our Data Analytics Data Science organization in a hybrid work model. In this role, you will implement data quality, data catalogue, lineage, and access governance activities on the Snowflake platform while collaborating with data owners, data stewards, Analytics, Data Science, and Data Governance teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Location: Hyderabad, India (Hybrid)

**Discover your role:**

- Profile assigned data assets within Snowflake to assess completeness, consistency, accuracy, uniqueness, and timeliness, producing reports that support data quality rule prioritization.
- Implement and monitor data quality rules using Snowflake Data Metric Functions, Dynamic Data Masking, and Row Access Policies, following agreed rule logic and coding standards.
- Generate exception reports and dashboards, track remediation activities, and raise issues or ambiguities to senior team members when needed.
- Maintain the Data Quality Rule Register, ensuring rule logic, thresholds, rationale, and change history documentation remain accurate and current.
- Manage catalogue entries within Horizon and support the documentation and validation of data lineage, classifications, ownership assignments, and provenance records.
- Support Snowflake role-based access control (RBAC) governance activities, access certification reviews, audit evidence preparation, and Data Marketplace catalogue management.
- You actively develop expertise in Snowflake governance and data quality practices while seeking feedback and continuous learning opportunities.
- You collaborate effectively with technical and business partners, sharing progress, supporting team objectives, and helping maintain high governance standards.

**This role requires:**

- Bachelors degree and 3+ years of relevant experience; advanced degree may be considered with 2+ years of relevant experience.
- Foundational hands-on experience with Snowflake, or a strong demonstrated ability and eagerness to rapidly develop Snowflake expertise, including SQL, Data Metric Functions, and Row Access Policies.
- Proficiency in SQL with the ability to write and review data quality rule logic and perform basic data transformations.
- Understanding of data quality concepts, including profiling techniques and quality dimensions such as completeness, consistency, accuracy, uniqueness, and timeliness.
- Knowledge of data governance principles, including metadata management, data ownership, and data catalogue practices.
- Ability to create clear, structured documentation, reports, dashboards, and governance records for technical and business audiences.
- Familiarity with Snowflake Horizon catalogue management, lineage documentation, classifications, and ownership assignment processes.
- Understanding of access governance concepts, including role-based access control (RBAC) and access certification activities.
- Exposure to a regulated industry, preferably pharmaceutical, or awareness of data integrity principles in a compliance-focused environment.
- Snowflake SnowPro Core certification or active progress toward certification.
- Familiarity with data catalogue platforms.
- Basic Python or dbt experience supporting data transformation activities.
- Exposure to data lineage concepts or related tooling.
- Familiarity with enterprise data governance tools and practices.
- Strong organizational skills with the ability to manage assigned tasks, meet deadlines, and raise blockers appropriately.
- Effective interpersonal and communication skills, with the ability to engage data owners and business partners on routine governance matters.
- Conscientious, diligent, collaborative, reliable, and committed to accuracy in governance and documentation activities.

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.

Associate Manager - Data Quality & Governance

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Manager Data Quality & Governance Operations to join our Data Governance team, supporting our Data Analytics and Data Science organization in a hybrid work model. In this role, you will drive the delivery of data quality controls, data cataloguing, lineage management, and access governance capabilities on the Snowflake platform while collaborating with Data Governance, IT, Analytics, Data Science, and business partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Location: Hyderabad, India (Hybrid)

**Discover your role:**

- Lead data quality workstreams within Snowflake, designing, implementing, and monitoring controls for assigned data domains while coordinating thresholds and remediation with data owners.
- Design and maintain auditable, version-controlled data quality rules using Snowflake Data Metric Functions, Dynamic Data Masking, and Row Access Policies aligned to business requirements.
- Monitor rule execution results, triage failures, and deliver exception reports and stakeholder dashboards that provide actionable insights to business teams, data stewards, and data owners.
- Maintain Data Quality Rule Registers and governance documentation that is current, audit-ready, and aligned to enterprise data governance standards.
- Lead catalogue maintenance and metadata management for assigned Snowflake assets within Horizon, ensuring consistent, business-meaningful documentation and inspection-ready lineage records.
- Produce lineage and provenance outputs that help Analytics and Data Science teams understand metric derivation, trustworthiness, and data usage.
- Manage day-to-day access governance activities for Snowflake role-based access control (RBAC) and attribute-based access control (ABAC) structures, supporting certification reviews, audit evidence preparation, and governed Data Marketplace operations.
- You proactively identify risks, continuously improve governance processes, and build productive relationships across technical and business teams while supporting leadership and team development.

**This role requires:**

- Bachelors degree and 7+ years of relevant experience; advanced degree may be considered with 6+ years of relevant experience.
- Solid hands-on experience with Snowflake, including Data Metric Functions, Dynamic Data Masking, Row Access Policies, Tasks, Streams, and Snowpark.
- Strong SQL proficiency with the ability to write, review, and optimize data quality rules, logic, and data transformations.
- Experience designing and implementing data quality controls within a structured governance, compliance, or regulated environment.
- Strong understanding of data governance principles, including data quality dimensions, data ownership models, metadata management, and governance frameworks.
- Experience maintaining data catalogues and business and technical metadata standards, including data lineage documentation and validation.
- Experience managing Snowflake access governance, including RBAC, ABAC, access certification activities, and audit-ready documentation.
- Ability to manage defined workstreams and coordinate delivery across multiple collaborator groups with limited supervision.
- Clear communication skills with the ability to explain data quality, governance, and lineage concepts to non-technical audiences.
- Experience in a regulated industry, preferably pharmaceutical, with familiarity with GxP data integrity requirements or equivalent frameworks.
- Snowflake SnowPro Core certification or equivalent demonstrated experience.
- Familiarity with Snowflake Horizon capabilities, including classification, governance policies, data sharing features, and metadata governance.
- Experience with Python or dbt for Snowflake-based data quality automation.
- Exposure to Data Marketplace or data-as-a-product operating models.
- Familiarity with enterprise data governance tooling.
- Diligent and dependable, with a commitment to delivering accurate, well-documented, audit-ready governance outputs.
- Strong problem-solving, risk identification, and continuous improvement attitude, with the ability to collaborate effectively across Data Governance, IT, Analytics, and business teams and support more junior colleagues.

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.

Associate QA Validation Specialist

The Associate QA Validation Specialist - validates and qualifies equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. This position is for the cleaning Validation team.

As an Associate QA Validation Specialist, a typical day might include the following:

- Generates, implements 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, corrective actions, change controls, SOPs, reports and other documentation

- Coordinates with other departments or outside contractors/vendors to complete validation tasks.

- May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.

- Manages projects and prepares status reports.

- May present at both internal and external (regulatory) audits

- Other duties assigned by management.

- Some travel may be required.

This role may be for you if you:

- Ability to maintain integrity and honesty at all times

- Ability to work independently or as part of a team

- Ability to communicate with transparency

- Continuously drive to improve processes for improved performance

- Demonstrate supportive behavior at all times

- Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)

- Gathers and organizes information

- Meets commitments on time

- Performs well-defined tasks

- Effective time management skills

- Seeks to identify continuous improvement needs

In order to be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and

- 0 2 years of relevant experience for an Associate

- 2+ years of relevant experience for a Specialist

- 5+ years of relevant experience for a Senior Specialist

- 8+ years of relevant experience for a Principal Specialist

- May substitute proven experience for education requirement

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 - $92,400.00

Supervisor, Quality Assurance Specialist (Overnight)

**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 Quality Assurance Specialist position. This position performs and leads activities on the floor in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

**Where & Where:**

- Location: Rensselaer, New York, United States
- Work model: Wednesday-Sunday, 3rd shift, 10:00 PM - 8:30 AM

**Discover your role:**

- Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
- Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication
- Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
- Provides consultation or advice in alignment with QA policies through a continuous on the floor presence, working with stakeholders by providing QA guidance to events or questions that may arise
- Perform activities associated with disposition of product (e.g., manufacturing record review, document review, source data review etc.).
- Review, edit, or approve Regeneron controlled documents
- Review and approve investigations associated with product or processes
- Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
- Supervising direct reports
- Participates with employee training to ensure that all requirements are met.
- Performs, minimally, monthly performance feedback meetings with direct reports.

**This role requires:**

- BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience
- Principal QA Specialist: 6+ years of relevant experience
- Staff QA Specialist: 8+ years of relevant experience
- Experience with sterile drug product manufacturing, fill finish and/or quality control testing
- Level will be determined based on experience

**This role may be for you if you**:

- Excel in a quality driven organization
- Have an understanding of biologics manufacturing operations
- Are organized and have an attention to detail
- Can prioritize multiple assignments and changing priorities
- Are able to stand for periods of time when performing tasks on the floor

**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

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

Senior Director, Clinical Diagnostics and Precision Medicine

**Build Our Future Together**

Regeneron is seeking an accomplished companion diagnostics (CDx) leader to set strategy and drive execution across a portfolio of therapeutic programs and technologies. As Senior Director, you will ensure that diagnostic strategies are integrated early and aligned with clinical development, regulatory submission, launch readiness, and patient access objectives. You will lead a team of diagnostic professionals and are responsible for overall diagnostic (including CDx) strategies for the entire pipeline of therapeutic areas and across all technologies; partnering across Regeneron and with IVD partners to ensure diagnostic and therapeutic success.

The role requires a leader who can translate biomarker hypotheses into fit-for-purpose diagnostic plans; guide assay selection, validation, and partner strategy; and influence across clinical, translational, regulatory, commercial, medical affairs, access, and external diagnostic organizations.

**When & where:**

- Location: Remote, USA
- Work model/flexibility: Remote

**Discover your role:**

- Set and lead global companion diagnostics strategy across the entire pipeline and all technologies, integrating diagnostic plans with clinical strategy, clinical development objectives & timelines, regulatory requirements, launch planning, and patient identification needs.

- Translate biomarker biology, mechanism-of-action hypotheses, clinical utility considerations into diagnostic target product profiles across relevant platforms, including NGS, PCR, immunohistochemistry, immunoassays, and emerging technologies.

- Define assay selection and development strategy from feasibility through analytical and clinical validation, regulatory submission, and post-approval lifecycle planning.

- Lead a team to successfully develop diagnostic strategies that support patient selection (and relevant exploratory datasets), stratification, monitoring, and evidence generation, accounting for timelines, cost, tissue requirements, turnaround time, reimbursement, global regulations and regional implementation.
- Provide executive oversight of external IVD sponsors, laboratory, and technology partner relationships, including partner selection, contracting strategy, governance, budgets, and escalation of critical issues.

- Accountable for operational readiness of CDx testing in clinical trials, including study startup, laboratory workflows, sample management, data transfer, and quality oversight.

- Shape global CDx regulatory strategy in partnership with Regulatory Affairs, including FDA, EU IVDR, PMDA, and other regional requirements, performance study design, submission content, labeling, and health authority interactions.
- Serve as senior CDx subject matter expert and strategic advisor to program teams and leadership, influencing decisions across translational medicine, clinical development, regulatory, biostatistics, clinical operations, commercial, medical affairs, market access, quality, and legal by communicating complex considerations clearly and credibly.

**This role requires:**

- Advanced degree (PhD, MD, MD/PhD, or equivalent) in molecular biology, pathology, translational medicine, oncology, biomedical engineering, diagnostics, or a related scientific discipline.

- 12 or more years of experience in companion diagnostics, IVD development, biomarker strategy, or translational medicine within pharma, biotech, or diagnostics, including progressive leadership responsibility.

- Demonstrated success leading CDx or biomarker-enabled diagnostic strategies through clinical development, regulatory submission, and therapeutic approval.

- Deep expertise in assay development, analytical and clinical validation, and clinical utility.

- Strong working knowledge of global CDx regulatory pathways, including FDA CDRH (PMA and supplemental submissions), EU IVDR, PMDA, performance studies, labeling, and post-approval obligations.

- Experience managing external diagnostic partners, IVD sponsors, central laboratories, CROs, and technology vendors within complex, timeline-sensitive programs.

- Proven people leadership, including mentoring talent, building capability, and setting priorities in a collaborative, accountable team environment.

\#PrecisionMedicineCDX

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)**

$242,000.00 - $403,300.00

Nationwide

Associate Director, Precision Medicine (Clinical Diagnostics)

**Build our future together:**

We're seeking an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. This role owns CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch translating biological insights and clinical hypotheses into validated, fit-for-purpose assays that support drug development decisions. You'll work at the interface of biomarker science, clinical development, regulatory, and external IVD partners to ensure diagnostics keep pace with therapeutic milestones.

**When & where:**

- Location: Uxbridge, United Kingdom (multiple locations are being considered for this role.)
- Work model/flexibility: 3 days onsite

**Discover your role:**

- Translate emerging biomarker and mechanism-of-action data into diagnostic target product profiles (TPPs), defining assay intent across platforms (Next Generation Sequencing, polymerase chain reaction, immunohistochemistry, immunoassays).
- Partner with translational and clinical teams to design biomarker strategies for patient selection, stratification, and enrichment, including sample strategy and specimen logistics.
- Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity, limit of detection, reproducibility), linking assay performance to clinical safety and efficacy endpoints.
- Set global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines.
- Select and oversee In Vitro Diagnostic (IVD) development partners; manage co-development scope, timelines, and quality expectations.
- Support global regulatory strategy and submissions (Food and Drug Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment.
- Ensure compliance with relevant standards (ISO 13485, ISO 14971, CLSI, IVDR, GCP alignment).
- Lead cross-functional working groups, translating scientific rationale into program plans and clear governance reporting.
- Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs.

**This role requires:**

- PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related translational/biomedical science field.
- 8+ years in diagnostics or translational research, with 4+ years leading biomarker-driven CDx or IVD programs bridging bench discovery and clinical application.
- Track record translating biomarker science into validated assays supporting drug approvals.
- Working knowledge of global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA).
- Ability to translate complex scientific and clinical data for cross-functional and executive audiences.
- Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions.

\#PrecisionMedicineCDX

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.

**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, GCP Quality Management - Global Development to join our Global Development Quality team, supporting our global clinical development organisation in a hybrid work model. In this role, you will lead risk-based quality management across clinical trials while collaborating with study teams, clinical functions, contract research organisations, and quality colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

**When & where:**

Multiple locations are being considered for this role (Hybrid)

**Discover your role:**

- Lead risk-based quality management across assigned clinical trials
- Drive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3
- Manage quality issues, audit responses, corrective actions, preventive actions, and trend analysis
- Partner with study leads, monitoring teams, and contract research organisations on site risks
- Escalate significant quality events and trends to Executive Quality Leadership
- Support inspection readiness, responses, and follow-up actions across relevant functions
- Manage onboarding, development goals, coaching, performance discussions, and team administration
- You champion quality, integrity, continuous learning, and trusted partnerships

**This role requires:**

- Bachelors degree and eight years relevant healthcare or pharmaceutical industry experience
- Quality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice experience
- Advanced risk-based quality management, risk assessment, and compliance knowledge
- Experience managing complex issues, regulatory inspections, and inspection readiness
- Subject matter expert, process owner, training, presentation, and staff management experience
- Process improvement, project management, prioritisation, and time management skills
- Advanced Microsoft Outlook, Word, Excel, and PowerPoint skills
- Strong communication, collaboration

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.

Senior Director, Fill Finish Facilities Maintenance

**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 Director, Facilities Maintenance to lead equipment maintenance and calibration for our manufacturing, laboratory, and warehouse operations, ensuring systems supporting drug product filling, visual inspection, device assembly, and packaging remain validated, compliant, and operational. 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: Onsite, Monday-Friday 8:00am-4:30pm

**Discover your role:**

- Own the site's preventive and corrective maintenance programs and calibration program for equipment supporting drug product filling, visual inspection, device assembly, packaging, and other manufacturing, laboratory, and warehouse systems.
- Partner with Manufacturing, Quality Assurance, Engineering, EHS, and Supply Chain leadership to align maintenance and calibration strategies with production schedules and business objectives.
- Drive reliability-centered maintenance and continuous improvement initiatives to minimize downtime and maximize equipment availability; own maintenance planning, scheduling, and contractor/vendor oversight.
- Establish and monitor KPIs (equipment uptime, mean time between failures, mean time to repair, maintenance backlog), leveraging OEE and CMMS data to drive condition-based and predictive maintenance.
- Maintain calibration schedules and traceability to national/international standards, ensuring records and systems are always audit-ready; own or support equipment-related deviation investigations, CAPAs, and change controls.
- Ensure all maintenance and calibration activities comply with cGMP, FDA, ISO 13485, and EU GMP Annex 1, and serve as a key stakeholder during regulatory inspections and audits.
- Build, mentor, and develop a high-performing team, establishing clear accountability, succession planning, and career development pathways; champion a culture of safety, quality, and compliance.
- Identify and lead initiatives to improve operational efficiency, reduce costs, and enhance equipment reliability, including support for facility expansion, equipment tech transfer, and new product introductions.

**This role requires:**

- BS/BA and 15+ years of progressive relevant experience in the pharmaceutical industry, or a MS degree and minimum 13 years of relevant experience.
- Experience managing maintenance/calibration programs and CMMS systems (e.g., Blue Mountain, SAP PM, Maximo) required; experience supporting drug filling, visual inspection, device assembly, and/or packaging strongly preferred.
- Strong working knowledge of cGMP, FDA, ISO 13485, and EU GMP Annex 1, with deep understanding of cleanroom systems and equipment supporting sterile/aseptic manufacturing.
- Proven ability to lead cross-functional teams and influence at all levels, with strong financial acumen managing multi-million dollar operating and capital budgets.
- Ability to work in a manufacturing environment, including cleanroom gowning and availability for after-hours facility emergencies, with excellent problem-solving, project management, and organizational skills, including communication during regulatory inspections.

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)**

$203,000.00 - $338,400.00

Temp - Associate QC Compliance Specialist

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

This position offers the opportunity to support quality, compliance, and continuous improvement activities across our QC laboratories, ensuring investigations and quality processes are completed to the highest standards in a GMP-regulated environment.

**When & Where:**

- **Location:**  Raheen, Limerick, Ireland.
- This role supports QC laboratories including Chemistry, Bioassay, Microbiology, and Virology.
- You will collaborate with cross-functional teams to drive compliance and quality excellence.

**What you'll do:**

- Lead and support laboratory investigations, deviations, and non-conformance activities.
- Write and review investigation reports and associated quality documentation.
- Perform root cause analysis and partner with teams to identify effective CAPAs.
- Support the timely implementation and monitoring of corrective and preventative actions.
- Identify recurring trends and recommend process improvements to strengthen Quality Control operations.

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

- Thrive in a fast-paced GMP-regulated environment with a strong focus on quality and compliance.
- Balance multiple priorities while meeting deadlines and maintaining attention to detail.
- Collaborate effectively with laboratory, quality, and cross-functional teams.
- Use critical thinking and problem-solving skills to resolve complex quality issues.
- Drive a culture of continuous improvement and operational excellence.

**Let's find out if we're a fit:**

- Requires a BS/BA in Chemistry, Biology, or a related scientific field, or an equivalent combination of education and experience.
- **Associate Specialist:**  Relevant degree and/or industry experience.
- **Specialist:**  2+ years of Quality Control or Analytical Sciences experience, including laboratory investigation experience in a cGMP environment.
- **Senior Specialist:**  5+ years of Quality Control or Analytical Sciences experience, including laboratory investigation experience in a cGMP environment.
- Experience with investigations, deviations, CAPAs, and root cause analysis is highly desirable.

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.

Quality Assurance Compliance Specialist, Change Control

**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 Quality Assurance Compliance Specialist, Change Control to support our Fill Finish facility. In this role, the Quality Assurance Compliance Specialist ensures quality and compliance to cGMPs, internal, external, and international requirements with respect to changing control activities. 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, 8:00 AM - 5:00 PM

**Discover your role:**

- As a Quality Compliance Specialist (Change Control), a typical day might include the following:
- Reviewing, assessing, editing, and approving change control documentation to ensure compliance with quality, regulatory and SOP requirements.
- Facilitating cross functional meetings and providing guidance and consultation to change proposal owners
- Developing relationships with end users and providing advice on best practices in Change Control
- Partnering with other members of the Quality Assurance team and/or end users of the system to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process, and associated procedures
- Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures and documentation.
- Supporting regulatory and customer audits.

- Experience in change control function is strongly preferred.

**This role might be for you if:**

- Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory.
- Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another.
- Ability to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment.
- Proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure or plan.
- Possess excellent interpersonal, written and oral communication skills with the ability to use active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships.
- Proficient digital literacy in Microsoft (MS) Word, Excel and PowerPoint required. Experience with Process Compliance/QUMAS heavily preferred.

**This role requires:**

Bachelors in a scientific or engineering discipline or related field with the following minimum amounts of relevant experience for each level, in a combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements.

- Associate Specialist 0-2+ years
- Specialist 2-5+ years
- Senior Specialist 5+ years

Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

\#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 - $110,000.00

Senior Manager Quality Assurance, Drug Product (Filling)

**Build our future together:**

Regeneron is currently seeking a Senior Manager Quality Assurance (QA) to join our internal QA Drug Product Manufacturing team. This role is responsible for quality floor oversight of the filling (i.e. equipment prep, formulation, and filling) operations for SA12.

**When & where:**

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

**Discover your role:**

- Provide leadership to multiple teams under your supervision
- Oversee quality of all equipment prep, formulation, and filling (multiple lines)
- Own programs that support the department, such as area walkthroughs
- Support the development and growth of your team, including your people leaders
- Serve as the leadership point of contact for escalation of events and process updates
- Demonstrate leadership in cGMP environments, including speaking to and preparing for regulatory inspections and audits
- Collaborate and communicate effectively cross-functionally
- Think critically and drive continuous process improvement
- Lead a GMP department through a fast-paced, dynamic environment

**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 Life Sciences or related field; or equivalent combination of education and experience and 8+ years of relevant experience
- Previous people leadership/supervisory experience
- Experience with drug product manufacturing and/or fill finish is preferred

\#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)**

$126,300.00 - $206,100.00

Manager, Integrated Data Review and Quality

**Build our future together:**

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for people with serious diseases.

We are seeking a Manager, Integrated Data Review & Quality to provide operational leadership for integrated data review activities across our clinical development portfolio. You will manage and directly contribute to study-level data review, help identify and resolve data quality risks, and partner with cross-functional teams to deliver high-quality, inspection-ready clinical data. You may also lead and develop Integrated Data Review & Quality staff while supporting a culture of collaboration, accountability, and continuous improvement.

**When & where:**

Hyderabad (hybrid)

**Discover your role:**

- Manage Integrated Data Review activities in line with established methodologies, standards, processes, and governance requirements.

- Develop, execute, and be responsible for Data Review Plans for assigned studies, ensuring data quality issues and risks are identified, tracked, escalated, and resolved.

- Lead Data Review Team meetings and facilitate discussions on findings, discrepancies, trends, risks, actions, and issue resolution.

- Review and interpret clinical, operational, safety, and external data using listings, visualizations, dashboards, patient profiles, analytical reports, and discrepancy reports.

- Present data review findings, risks, trends, and recommendations to study teams and cross-functional stakeholders.

- Manage study-level queries and discrepancies, including investigation, documentation, blocking issue, corrective action, resolution, and closure.

- Support database readiness and database lock by ensuring data review activities and quality issues are completed and resolved on time.

- Apply risk-based approaches to identify critical data and quality risks aligned with study objectives and critical-to-quality factors.

- Act as a subject matter expert for Integrated Data Review, Data Review Plans, discrepancy management, risk identification, and data quality issue resolution.

- Support SOPs, work instructions, templates, training materials, guidance, metrics, lessons learned, and process improvements.

- Contribute to initiatives involving analytics, automation, AI-enabled solutions, and integrated review across clinical and external data domains.

- Lead, coach, mentor, and develop team members, and support workload planning, resource allocation, priorities, and study deliverables, as applicable.

**This role requires:**

- A bachelor's degree in Life Sciences, Statistics, Computer Science, or a related field.

- At least 7 years of direct Clinical Data Management experience within biotechnology, pharmaceutical, CRO, or healthcare.

- At least 4 years of experience in Integrated Data Review, Data Quality Management, Risk-Based Data Management, or related clinical data review activities.

- At least 2 years of people management, team leadership, or equivalent experience leading study-level or cross-functional initiatives.

- Strong knowledge of clinical data management, integrated data review, data quality management, issue management, and clinical trial data flow.

- Experience developing and executing Data Review Plans and leading Data Review Team meetings.

- Experience reviewing clinical, operational, safety, and external data to identify trends, anomalies, inconsistencies, and quality risks.

- Experience leading study-level queries and discrepancies and driving root-cause analysis, corrective actions, and resolution.

- Solid understanding of Risk-Based Data Management and Risk-Based Quality Management principles.

- Solid understanding of ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, global data privacy requirements, and inspection readiness.

- The ability to lead and influence in a matrix organization and build strong partnerships across clinical development functions.

- Strong analytical, strategic, critical-thinking, stakeholder management, facilitation, negotiation, and communication skills.

- The ability to manage multiple studies, priorities, and competing deliverables in a fast-paced environment.

- Willingness to travel up to 25%, when required.

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.