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Senior Manager, QA Auditing
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Full-time
- Apply remote type Hybrid locations Andover, MA time type Full time posted on Posted 9 Days Ago job requisition id R-02480 The Sr. Manager, QA Auditing will be responsible for scheduling and leading domestic and international Corporate and Regional Compliance Audits, including internal audits of Sarepta GxP facilities and external audits of Sarepta approved vendors in accordance with Sarepta policies and procedures.
- He/she will manage Sarepta’s Corporate GxP Auditing Program to include oversight of audit programs established for cGMP and GDP (as applicable EU Distribution).
- Conduct GMP external audits of Sarepta approved vendors including Contract Manufacturers, APIs, Drug Product, Primary and Secondary Packaging, Contract Laboratories, 3PL and transport vendors.
- Manage Sarepta’s Approved Vendor Management program as applicable to all current and new vendors.
- Understanding of GMP/GDP compliance requirements; understanding of FDA and Global GMP Quality Requirements.
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