Senior Manager, Internal Audit

Discover Your Role
- Maintain up-to-date expertise in global GxP regulations and standards (21 CFR Chapter 21, Eudralex Volume 4 and annexes, ISO standards, ICH, WHO, IPEC) and internal policies; track and communicate industry trends, agency expectations, and warning letters
- 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, QA, operations, audit clients) to meet audit schedules, quality deliverables, and organizational goals
- Provide leadership and subject-matter guidance to auditors; recruit, select, train, assess external proxy auditors; coach/mentor and develop internal GMP auditing staff; maintain training and qualification programs
- Ensure auditing processes meet regulatory and industry requirements; document and assess deviations and changes per IOPS processes; uphold safety and operational standards
- Develop and present metrics and targets (including RTO) to senior leadership
- Drive continuous improvement by reassessing auditing processes and proactively preventing deviations/operational issues
- Accountable for team performance and outcomes of internal/external audit programs; support inspections as needed

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

Application Instructions
- Apply now