Quality Compliance Director
6 dagen geleden
The Associate Director, Quality Compliance at Organon is responsible for leading the Audit & Supplier Quality Management team to ensure compliance with cGMP, regulatory, and QMS requirements. The ideal candidate will have a strong background in quality systems, GMP compliance, and regulatory requirements. They will also be proficient in auditing, supplier quality management, and team leadership.
Main Responsibilities
- Lead site internal audit program, covering end-to-end, system-based, and Walk Through audits.
- Lead Health Authority inspections, notified body audits, customer audits, and Global GMP audits.
- Review and approve audit reports, CAPA responses, and monitor completion.
- Perform internal and for-cause audits and participate in opportunities to audit other Organon sites.
- Generate annual audit schedules and performance reports.
- Promote a quality compliance culture and audit program performance.
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