Senior Director, Manufacturing Technical Sciences Quality Assurance (hybrid)

Vrtx

Boston, MA, United States
Base: $216,000 - $324,000; bonus/equity: eligible ...
On-site
Cell & genetic therapies product portfolio
Cmc and analytical quality standards
Quality assurance oversight for analytical development
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.
  • The role requires a minimum of 3 days per week on site in the Boston Seaport and is eligible for an annual bonus and annual equity awards.

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

Base: $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 for analytical development
  • QA technical oversight through Change Management
  • Quality SME on CMC team
  • QA oversight of the stability program
  • Quality risks and improvement opportunities
  • Health Authority inspections support

Nice-to-have

  • Influencing/building/promoting a culture of Quality
  • Critical thinking and problem-solving skills
  • Mentoring, collaborating and building relationships
  • Building alignment across diverse perspectives

Key Requirements

  • 15+ years of relevant industry experience
  • 10 years leadership experience
  • Bachelor's or Master's degree
  • In-depth global regulatory agency knowledge
  • Experience with CDMO oversight
  • Experience with regulators (e.g., NDA, BLA, MAA submissions and/or inspections)
  • 15% Travel required internationally

Work Rights

Not specified

Tailored Resume

Cover Letter