Associate Director, GMP Operational Quality - Cell & Genetic Therapies
$156.6k - $234.8kVertex Pharmaceuticals
Associate Director overseeing GMP operational quality for cell and genetic therapies at a rare disease-focused pharmaceutical company. Responsible for leading a quality team, managing compliance with regulatory requirements, and developing personnel while supporting manufacturing operations.
Responsibilities
- Lead quality team providing oversight and support to GMP business activities
- Oversee CMO and vendor performance including quality agreements and compliance
- Develop and maintain compliant quality processes supporting GMP manufacturing
- Drive continuous process improvements and lead performance tracking and reporting
- Manage talent acquisition, performance reviews, and individual career development
Requirements
- Bachelor's degree in scientific or allied health field
- 8+ years work experience and 2+ years management experience
- In-depth knowledge of cGMP principles and global GMP requirements
- Demonstrated success building and managing high-performing teams
- Experience leading investigations, root cause analysis, and CAPA processes
- Proficiency with electronic document management systems (QDocs, Trackwise, Veeva)
- Strong cross-functional communication and influence skills
Compensation: $156,600-$234,800 base
Vacancy posted 15 days ago
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