Director of QualityGreen Life Science • Boston, MA, US
Director of Quality
Green Life Science • Boston, MA, US
5 hours ago
Job type
- Full-time
Job descriptionBachelor's in science or engineering (advanced degree a plus) 10+ years in GMP pharmaceutical manufacturing; 5+ years in Quality leadership Strong command of FDA / EMA regulations, ICH guidelines, and CDMO environment Proven success managing inspections, audits, and client relationships Experience with aseptic, biologics, or high-potency APIs is a plus Lead quality for a growing CDMO with diverse product portfolios Influence site strategy and partner closely with clients and regulators Competitive compensation, bonus, benefits, and development opportunities
We're hiring a Director of Quality to lead QA / QC operations at our U.S.-based Contract Development & Manufacturing Organization (CDMO). This senior leader will ensure GMP compliance, oversee product release, and drive quality excellence across our clinical and commercial manufacturing programs.
What You'll Do
- Lead QA, QC, and Quality Systems teams; build a strong quality culture
- Oversee batch record review, product disposition, and client quality interactions
- Maintain and improve GMP compliance, CAPA, deviations, change control, and training systems
- Prepare the site for regulatory inspections (FDA, EMA) and client audits
- Provide quality oversight for manufacturing, tech transfers, and validation activities
- Drive continuous improvement, data integrity, and inspection readiness
What We're Looking For
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Director Of Quality • Boston, MA, US