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Director of Quality Assurance
Job in
Gastonia, Gaston County, North Carolina, 28054, USA
Listed on 2026-02-12
Listing for:
Metric Bio
Full Time
position Listed on 2026-02-12
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist
Job Description & How to Apply Below
Context
Global CDMO
About the JobMetric 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
- 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
- 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
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