QA Operations - Drug Product, QA Manager

📋 Description

• Represent QA on internal/external project teams, audits, inspections.
• Review and manage batch records from CMOs, including release activities.
• Ensure CMO SOPs/MBRs meet cGMP; review deviations and CAPAs.
• Lead Drug Product disposition.
• Escalate manufacturing deficiencies to management and drive resolution with CMOs.
• Support regulatory filings and audits of CMOs.

🎯 Requirements

• Bachelor's degree in science; 8+ years in biopharma or CRO.
• Strong GMP/SOP/Quality Systems knowledge (Lot Release, CAPA, Deviations).
• Strong knowledge of FDA and clinical trial regulations.
• Experience in QC, Analytical Development, and process validation preferred.
• Excellent verbal and written communication; customer focus.
• Excellent organizational skills; detail-oriented; multitasking ability.

🎁 Benefits

• 401(k) with employer match
• Pre-tax commuter benefits
• Flexible PTO and company holidays
• Subsidized lunch and parking on in-office days
• Health Savings Account (HSA) and FSAs
• Career pathing and ongoing education programs