Associate Director, GMP Quality Assurance

📋 Description

• Lead QA for downstream manufacturing and devices (prefilled syringes/auto-injectors).
• Maintain and enhance GMP quality systems: docs, change control, deviations, CAPA, quality events.
• Ensure readiness for regulatory inspections and maintain inspection readiness.
• Develop, monitor, and report quality metrics to drive GMP compliance.
• Foster a culture of quality, data integrity, patient safety, and collaboration.
• Collaborate cross-functionally to solve problems and drive improvements in quality systems.

🎯 Requirements

• Bachelor’s degree in a relevant scientific discipline.
• 7+ years in GMP QA in biotech/pharma, with monoclonal antibodies or biologics.
• Knowledge of medical device QMS, 21 CFR Part 4/820, ISO 13485, ISO 14971.
• Experience with analytical instrumentation, method validation, investigations, and stability programs.
• Experience using electronic QMS to track quality tasks and KPIs.
• Strong oral and written communication and collaboration skills.

🎁 Benefits

• Culture based on C.O.R.E. values: Caring, Original, Resilient, Egoless.
• Fast-paced, dynamic environment where you wear multiple hats.
• Competitive compensation: base salary, bonus, equity, health, welfare, retirement.
• Generous PTO and annual company shutdowns plus paid sick leave.
• Commitment to professional development and growth resources.
• Regular all-team in-person meetings to build relationships.