Associate Director, Product Quality (hybrid)

Vrtx

Boston, MA, United States
Base: $151,200 - $226,800; bonus/equity: eligible ...
On-site
End-to-end quality oversight
Clinical development and commercialization
Cgmp regulation compliance
The Associate Director, Product Quality is accountable for end-to-end quality oversight of small molecule program(s) throughout their lifecycle, including clinical development, commercialization, and post-approval activities

Job Summary

  • The Associate Director, Product Quality is accountable for end-to-end quality oversight of small molecule program(s) throughout their lifecycle, including clinical development, commercialization, and post-approval activities.
  • This role involves setting and maintaining overall Quality strategies, establishing product quality standards, and ensuring alignment with industry and regulatory expectations.
  • The candidate will foster strong collaboration with internal and external stakeholders, provide strategic guidance, and champion a consistent approach to Quality and compliance standards.

Matching Summary

The Associate Director, Product Quality is accountable for end-to-end quality oversight of small molecule program(s) throughout their lifecycle, including clinical development, commercialization, and post-approval activities.

Salary

Base: $151,200 - $226,800; Bonus/Equity: Eligible for annual bonus and equity awards; Benefits: Market-leading benefits package

Skills & Requirements

Must-have

  • End-to-end quality oversight
  • Clinical development and commercialization
  • cGMP regulation compliance
  • Product quality standards
  • Risk identification and mitigation
  • Cross-functional collaboration

Nice-to-have

  • Quality by Design principles
  • Emerging industry trends
  • External environmental monitoring
  • Combination product development

Key Requirements

  • 8+ years of experience in pharmaceutical/biopharmaceutical industry
  • Bachelor’s or Master’s degree in a Scientific/Technical/Business discipline
  • 3+ years of staff management or leadership experience
  • Expertise in cGMP compliance and FDA guidelines
  • Experience with regulatory submissions and inspections

Work Rights

Not specified

Tailored Resume

Cover Letter