Director, GPS Quality & Compliance
About The Position
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.
Requirements
- 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
Nice To Haves
- 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
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
