Associate Director, Gmp Qa

Formation Bio

Boston, MA, USA
$154,500 - $202,000 py
On-site
Gmp regulatory compliance
Cdmo oversight
Batch release
Ensure compliance with global GMP regulations and internal procedures for all regulated activities

Job Summary

  • Ensure compliance with global GMP regulations and internal procedures for all regulated activities.
  • Review and approve GMP documents, perform QA review of batch records, and support investigations into quality events.
  • Champion a culture of quality, transparency, and continuous improvement, while exploring AI integration for enhanced efficiency.

Matching Summary

Ensure compliance with global GMP regulations and internal procedures for all regulated activities.

Salary

$154,500 - $202,000

Skills & Requirements

Must-have

  • GMP regulatory compliance
  • CDMO oversight
  • batch release
  • deviation investigations
  • quality agreements

Nice-to-have

  • AI integration for quality
  • dynamic environment adaptability
  • patient safety commitment

Key Requirements

  • 8+ years in GMP Quality Assurance
  • Bachelor's degree in scientific discipline
  • Experience with CMO oversight

Work Rights

Not specified

Tailored Resume

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