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About the Role

Regeneron's Global Patient Safety (GPS) organization is seeking a Director, GPS Quality & Compliance to support quality event management and inspection readiness programs. This role partners closely with leadership and operates as a functional leader coordinating and delegating work to ensure consistent, high-quality program delivery within a fast-growing, science-driven organization.

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.
• Maintain inspection readiness materials and translate regulatory frameworks into practical action.
• Champion a culture of 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.
• Coordinate across teams and functions regardless of formal reporting lines.

Requirements

• A Bachelor's degree required; advanced degree preferred.
• 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.

Location

• Warren, NJ
• Armonk, NY
• Tarrytown, NY
• Cambridge, MA

Work Type

• 4 days/week on-site
• 20% travel

Experience Level

• 12+ years pharmaceutical industry experience

Education Level

• Bachelor's degree required
• Advanced degree preferred

Salary/Compensations

• $183,100.00 - $305,200.00

Benefits

• 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

About the Company

• Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
• We believe we do our best work when we are together.
• Many roles are required to be performed on-site.

Equal Opportunity

• 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.
• We will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.