Manager GMP Compliance & Inspections

Role Summary

The Manager GMP Compliance & Inspections will work with cross-functional teams to drive activities to prepare, execute and follow through on audits and inspections at Regeneron’s manufacturing site IOPS. This role will engage with internal auditors, partner auditors and regulators and play a leading role in the preparation and execution of regulatory inspections, partner audits and internal audits, as well as follow up post audit and inspection on any items requiring response and action.

Responsibilities

• Working with department leaders and cross functional teams to educate, build and maintain an inspection readiness structure across the organization
• Supporting regulatory inspections and partner audits in the creation, maintaining and managing inspection content, ensuring it is organized, current and readily accessible at all times
• Responding to incoming inquiries during inspections and audits and ensuring timely and accurate responses
• Evaluating outcomes of regulatory authority inspections/partner and other audits to identify near misses, lessons learned and other standard processes and working cross-functionally to ensure identified process or system improvement opportunities are sustainably implemented
• Establishing and maintaining a communication process mechanism to site management on the status of regulatory inspection readiness and CAPA commitments
• Evaluating and leading proposed commitments to regulatory authorities/audit bodies in response to inspection/audit findings
• Working collaboratively with commitment owners to ensure that all commitment timelines are met via proactive CAPA tracking, and confirming their timely closure and ensuring suitable effectiveness checks are in place
• Utilizing strong critical thinking skills to serve as a thought partner to the GMP Compliance and Inspections leadership with regard to complex problems
• Generating, developing and reporting metrics / trends for program adherence to requirements and effectiveness
• Supporting and leading teams implementing practices and improvements to make IOPS inspection-ready at all times
• Liaising with partners on audit/inspection and quality related matters to provide guidance and advice
• Participating on internal committees/teams, as required
• Coordinating Regeneron information to support regulatory requests for paper inspections and/or observation responses

Qualifications

• Required: 6+ years of related experience for Associate Manager; 7+ years for Manager; 8+ years for Sr Manager; level determined by qualifications relevant to the role
• Optional: May substitute proven experience for education requirement
• Preferred: Are knowledgeable in industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA)
• Preferred: Excel in a quality driven organization
• Preferred: Have an understanding of biologics manufacturing operations

Education

• Bachelor’s degree in Life Sciences