GMP Quality Senior Manager
Job Summary
Managing quality activities remotely, the full-time Sr. Manager, GMP Quality will oversee cross-functional project teams, conduct product release activities, and ensure compliance with GMP standards in pharmaceutical manufacturing.
Key responsibilities
- Serve as the QA representative on project teams and manage quality activities with CMOs and third-party suppliers
- Conduct product release activities and review Master Batch Records and stability documentation
- Lead Quality Events, Investigations, CAPAs, and manage continuous improvement of GMP quality systems
Required qualifications
- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, Engineering, or a related scientific discipline
- Experience in GMP/GxP pharmaceutical manufacturing and product release
- Knowledge of Master Batch Records (MBR) and Executed Batch Records (EBR)
- Familiarity with Quality Events, Investigations, and CAPA processes
- Experience with technical transfers and validation protocols in a pharmaceutical setting
Complete Job Description
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