$216,000 - $324,000; bonus/equity: eligible for an...
Hybrid
Cell & genetic therapies product portfolio
Cmc and analytical quality standards
Quality assurance oversight
The Senior Director, Manufacturing Technical Sciences QA is accountable for end-to-end technical quality oversight of cell and genetic program throughout clinical development, commercialization, product launch and post approval lifecycle management activities
Job Summary
The Senior Director, Manufacturing Technical Sciences QA is accountable for end-to-end technical quality oversight of cell and genetic program throughout clinical development, commercialization, product launch and post approval lifecycle management activities.
This role will lead a team of process and analytical QA personnel and closely partner with operational stakeholders to participate in Cell & Genetic therapies projects, quality oversight of technical change management from initiation to implementation and closure.
Vertex offers inclusive market-leading benefits including medical, dental and vision benefits, generous paid time off, educational assistance programs, and a 401(k).
Matching Summary
The Senior Director, Manufacturing Technical Sciences QA is accountable for end-to-end technical quality oversight of cell and genetic program throughout clinical development, commercialization, product launch and post approval lifecycle management activities.
Salary
$216,000 - $324,000; Bonus/Equity: eligible for annual bonus and annual equity awards; Benefits: inclusive market-leading benefits
Skills & Requirements
Must-have
Cell & Genetic Therapies product portfolio
CMC and Analytical Quality standards
Quality Assurance oversight
Health Authority inspections
manufacturing and compliance continuous improvements
Nice-to-have
influencing/building/promoting a culture of Quality
apply critical thinking and problem-solving skills
mentor, collaborate and build relationships
building alignment across diverse perspectives
Key Requirements
Bachelor's or Master's degree
15+ years industry experience
10 years leadership experience
In-depth global regulatory agency knowledge
Quality experience of on-site manufacturing and CDMO oversight