Associate Director, GMP Operational Quality (Biologics) Wed-Sat
Vertex Pharmaceuticals · Boston, MA
QualityFull-time$157k–$235kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Associate Director overseeing GMP operational quality teams at Vertex's Boston facility, responsible for team leadership, personnel development, and ensuring quality compliance across manufacturing and testing operations. This on-site position involves managing quality assurance programs, leading investigations, and coordinating with clinical and manufacturing functions.
What they're looking for
- In-depth knowledge of cGMP principles and global GMP requirements in pharmaceutical manufacturing
- Proven experience building and managing high-performing teams with strong coaching abilities
- Substantial background leading complex projects and cross-functional teams within timelines
- Demonstrated expertise in quality investigations, root cause analysis, and CAPA development
- Strong cross-functional communication skills with ability to influence stakeholders
- Experience with regulatory compliance, GCP standards, and audit management
- Risk-based decision-making capability and exposure to multiple regulatory agencies
What you'll be doing
- Lead quality operations team supporting GMP manufacturing and commercial drug product testing
- Manage QA programs including on-the-floor activities and facility walkthroughs
- Conduct quality issue investigations, root cause analysis, and develop corrective/preventive actions
- Develop risk-based audit plans and lead compliance audits for clinical programs
- Provide team management including talent acquisition, performance reviews, and succession planning
Privacy & handoff
This role links to Vertex Pharmaceuticals's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.