Metric Bio
Title:
Director, QA Operations Context:
Global CDMO Candidates must be based in the US for consideration About the Job
Metric Bio is partnered with a rapidly scaling biologics CDMO seeking a Director, QA Operations to lead quality oversight across biologics manufacturing, validation, and batch release activities. This role sits on the site Quality leadership team and plays a critical part in supporting facility startup and commercial operations. Responsibilities
Lead QA Operations, including QA Product, Validation, and Batch Review & Release teams Provide GMP oversight for biologics manufacturing and associated support functions Ensure compliant batch disposition in line with cGMP, FDA, and EU requirements Oversee quality systems including deviations, CAPAs, change control, and validation Support PPQ, tech transfer, and commercial manufacturing activities Drive a strong quality culture and continuous improvement initiatives Partner cross-functionally and with external stakeholders to ensure Quality Agreement alignment Ideal Profile
Deep experience in biologics manufacturing and GMP environments Proven QA leader with experience building and leading teams Strong background supporting FDA and EU regulatory inspections Effective collaborator with a pragmatic, operational mindset Education & Experience
Bachelor’s degree in life sciences or engineering (advanced degree preferred) 10+ years of GMP Quality experience in biopharmaceutical manufacturing 7+ years in QA leadership or management roles Seniority level
Director Employment type
Full-time Job function
Quality Assurance and Manufacturing Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Director, QA Operations Context:
Global CDMO Candidates must be based in the US for consideration About the Job
Metric Bio is partnered with a rapidly scaling biologics CDMO seeking a Director, QA Operations to lead quality oversight across biologics manufacturing, validation, and batch release activities. This role sits on the site Quality leadership team and plays a critical part in supporting facility startup and commercial operations. Responsibilities
Lead QA Operations, including QA Product, Validation, and Batch Review & Release teams Provide GMP oversight for biologics manufacturing and associated support functions Ensure compliant batch disposition in line with cGMP, FDA, and EU requirements Oversee quality systems including deviations, CAPAs, change control, and validation Support PPQ, tech transfer, and commercial manufacturing activities Drive a strong quality culture and continuous improvement initiatives Partner cross-functionally and with external stakeholders to ensure Quality Agreement alignment Ideal Profile
Deep experience in biologics manufacturing and GMP environments Proven QA leader with experience building and leading teams Strong background supporting FDA and EU regulatory inspections Effective collaborator with a pragmatic, operational mindset Education & Experience
Bachelor’s degree in life sciences or engineering (advanced degree preferred) 10+ years of GMP Quality experience in biopharmaceutical manufacturing 7+ years in QA leadership or management roles Seniority level
Director Employment type
Full-time Job function
Quality Assurance and Manufacturing Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr