Senior Manager, Quality Operations

📋 Description

• Own and run day-to-day QA operations across programs.
• Maintain and improve the QMS (docs, training, deviations, CAPA).
• Support batch record reviews and ensure documentation is inspection-ready.
• Coordinate QA disposition and release of clinical drug products.
• Manage supplier, vendor, and CDMO qualification and escalation.
• Lead training programs and aseptic technique qualification.

🎯 Requirements

• 5+ years in GMP quality operations for clinical manufacturing.
• Experience maintaining QMS: document control, training, deviations, CAPA.
• QA disposition and release of clinical drug products experience.
• Coordinate supplier, vendor, and CDMO qualification and escalation.
• Lead training programs and aseptic technique qualification.
• Bonus: GCP environments and data integrity knowledge.

🎁 Benefits

• Medical, dental, and vision insurance for you and family.
• 401(k) with 4% matching.
• Flexible time off and 10 company holidays.
• Paid parental leave.
• Annual learning and development stipend.
• Daily Retro lunch and snacks.