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Director / Sr. Director, Global GMP QA
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Full-time
- We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director/Sr. Director, Global GMP Quality Assurance.
- The Director/Sr. Director, Global GMG Quality Assurance will act as the Head of GMP QA and has overall responsibility for establishing QMP QA quality objectives, managing the GMP QA team, and representing GMP Quality on product program teams.
- The Director/Sr. Director, Global GMP Quality has multiple direct reports, is a member of the Quality Assurance Leadership Team (QALT) and reports to the Vice President, Quality Assurance.
- Lead, manage, and execute ongoing maintenance and continuous improvements of GMP QA quality systems, including but not limited to, compliance and follow through to completion of audits, documents, deviations, CAPA, change control, complaints, management review, validation, and data integrity.
- Lead the Quality representation for Tech Transfer of investigational products, including active input and decision making related to transfer strategy, protocol development, transfer execution, and final approval.
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