Director of Quality

Director of Quality 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

Bachelor’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 environmentProven success managing inspections, audits, and client relationships

Experience with aseptic, biologics, or high-potency APIs is a plus

Why Join Us?

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

Location: Boston, MA

Salary: $150,000.00–$195,000.00

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