Senior Manager, Internal Audit

About the role

The Senior Manager will provide professional expertise, leadership, oversight and assist with strategic planning for the Regeneron Industrial Operations and Product Supply (IOPS) Quality Auditing function. They will manage internal audit programs and perform internal audits for Regeneron IOPS, with primary emphasis on GMP, IT and Quality audits that may impact GMP operations and/or products.

Responsibilities

• Maintain up-to-date expertise in global GxP regulations and standards (Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc)
• Lead enterprise audit programs (internal and external) across GMP, IT, and quality: set strategy, build schedules, plan, assign, and personally lead/participate in audits; ensure inspection readiness
• Manage cross-functional and supplier relationships (procurement, manufacturing, quality, external manufacturing, quality assurance, operations, audit clients) to meet audit schedules, quality deliverables, and organizational goals
• Provide leadership and subject-matter guidance to auditors; recruit, select, train, and assess external proxy auditors; coach, mentor, and develop internal GMP auditing staff; maintain robust training and qualification programs
• Ensure auditing processes meet regulatory and industry requirements; carry out adherence to procedures; document and assess deviations and changes per IOPS processes; uphold safety and operational standards
• Develop, maintain, and present metrics and targets (including RTO) to senior leadership to measure strategy execution and the health of quality auditing systems
• Drive continuous improvement by periodically reassessing auditing processes; translate ambiguity into actionable plans; proactively solve problems to prevent deviations and operational issues
• Accountable for team performance and outcomes of internal/external audit programs, including managing leaders where applicable; support inspections as needed

Requirements

• BS/BA in Life Sciences; or equivalent combination of education and 8+ years of relevant experience
• Experience with quality systems and auditing
• Previous leadership/supervisory experience