Director, GPS Quality & Compliance

Regeneron Pharmaceuticals, Inc (USA); Kentucky; On-site; USD 183,000 - 305,000; Full time

Benefits offered by this job

Annual bonuses or other incentivePlans

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, v

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc is seeking a Director for GPS Quality & Compliance to lead quality event management and inspection readiness programs. You will partner with GPS leadership and Global Development Quality to ensure high-quality program delivery, guiding teams through GCP/GVP audits and regulatory readiness.

The role emphasizes data-driven insights, escalation leadership, and cross-functional collaboration across GDQ, QPPV Office, Regulatory Affairs, and vendors.

Qualifications

• Bachelor's degree required; advanced degree preferred; minimum 12 years of pharmaceutical industry experience.
• Deep knowledge of global PV regulations, quality management systems, and inspection readiness frameworks (FDA CFR, GVP Modules).
• Experience facilitating FDA and EMA/MHRA inspections (GCP and GVP), including direct experience as 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.

Responsibilities

• 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.
• Translate regulatory frameworks into practical action and maintain inspection readiness materials.
• Champion accountability and continuous improvement, acting as an escalation point when issues arise.
• Review quality metrics and trend analyses to shape clear, actionable recommendations for senior leadership.
• Present governance topics and quality insights to senior team members with confidence and clarity.
• Lead through influence, coordinating across teams and functions regardless of formal reporting lines.

Skills

Quality event management

Inspection readiness

GCP/GVP audits

Cross-functional collaboration

Analytics & metrics

Education

Bachelor's degree

Advanced degree preferred

Tools

FDA CFR

GVP Modules

QMP governance

Job description

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

If you have any questions, please speak with your recruiter.

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 Traveller 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.

Salary Range (annually) $183,100.00 - $305,200.00

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
• 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/. For other locations, additional information will be provided during the recruitment process.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.