Director, GPS Quality & Compliance

Regeneron · Warren +3 more

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QualityFull-time$183k–$305kCompany career page

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What they're looking for

Bachelor's degree required; advanced degree preferred
Minimum 12 years pharmaceutical industry experience
Deep knowledge of global PV regulations, FDA CFR, and GVP modules
Demonstrated experience facilitating FDA and EMA/MHRA inspections as point of contact
Proven track record overseeing QMP governance and cross-functional quality oversight
Experience managing relationships across quality, regulatory, and vendor functions
People management experience preferred

What you'll be doing

Lead functional workstreams in quality event management and inspection readiness programs
Serve as primary contact during GCP and GVP audits, guiding preparation and response
Maintain inspection readiness materials and translate regulatory requirements into operational guidance
Review quality metrics and trend analyses to inform leadership recommendations
Coordinate across teams and functions to drive accountability and continuous improvement

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Date posted4 days ago

Last source check1 day ago

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