Senior Manager, Internal Audit
About the role
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.) and internal policies; track and communicate industry trends, agency expectations, and warning letters.
Responsibilities
- 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
Qualifications
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.
Skills
Expertise in global GxP regulations and standards; strong communication and leadership skills; ability to manage cross-functional teams; knowledge of internal policies and industry trends; experience with quality systems and auditing; previous leadership/supervisory experience.
Benefits
Not specified
Pay
$126,300.00 - $206,100.00 annually
Schedule
Monday-Friday, 8am-4:30pm; 25-30% travel domestic & occasionally international