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Director of Quality (Boston)
Director of Quality (Boston)Green Life Science • Boston, MA, United States
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Director of Quality (Boston)

Director of Quality (Boston)

Green Life Science • Boston, MA, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Were 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 Youll 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 Were Looking For

  • Bachelors 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

    • 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
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