Senior Manager, Quality Control GMP

📋 Description

• Provide scientific leadership for QC GMP activities, including analytical method transfer
• Serve as a QC subject-matter expert for release and stability testing, including data review
• Lead or support investigations involving deviations, out-of-specification (OOS), and out-of-trend
• Partner with Analytical Development and CMC teams to facilitate successful method transfers to QC
• Oversee QC activities performed by contract testing laboratories and manufacturing partners
• Contribute to the development and execution of control strategies for small-molecule drug substance

🎯 Requirements

• Ph.D. in Chemistry, Pharmaceutical Sciences, or a related discipline with significant QC or
• 5–8 years of experience in QC testing and GMP compliance supporting clinical and/or
• Strong expertise in analytical techniques used for small-molecule pharmaceuticals, including
• Deep understanding of analytical method validation, transfer, qualification, and lifecycle
• Demonstrated experience leading or supporting deviation, OOS, and OOT investigations and CAPA
• Working knowledge of global regulatory requirements, including FDA, EMA, ICH guidelines, and

🎁 Benefits

• Salary range of $155,000–$185,000 USD.
• Target bonus of 15%.
• Ongoing stock awards.
• 100% company-paid medical, dental, and vision premiums for employees and their families.
• Company funding of up to 75% of in-network deductibles to help reduce out-of-pocket healthcare
• 401(k) matching with immediate vesting.