Director, Clinical Quality Assurance

Dyne Therapeutics

Waltham, MA, United States
Base: $190,000 - $232,800 usd; bonus/equity: not s...
On-site
Gcp compliance and quality oversight
Risk-based strategies
Audits and inspections
Dyne Therapeutics is seeking a Director of Clinical Quality Assurance to lead GCP compliance and quality oversight for their clinical programs focused on genetically driven neuromuscular diseases. The ideal candidate will have extensive experience in the pharmaceutical or biotechnology industry, particularly in Clinical Quality Assurance, and will play a crucial role in ensuring regulatory compliance and quality risk management

Job Summary

  • The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs and commercial products.
  • This role is responsible for developing and implementing risk-based strategies; managing audits, inspections, and vendor oversight; and ensuring global regulatory compliance.
  • The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

Matching Summary

Match Score: 85

Dyne Therapeutics is seeking a Director of Clinical Quality Assurance to lead GCP compliance and quality oversight for their clinical programs focused on genetically driven neuromuscular diseases. The ideal candidate will have extensive experience in the pharmaceutical or biotechnology industry, particularly in Clinical Quality Assurance, and will play a crucial role in ensuring regulatory compliance and quality risk management.

Salary

Base: $190,000 - $232,800 USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • GCP compliance and quality oversight
  • risk-based strategies
  • audits and inspections
  • vendor oversight
  • global regulatory compliance
  • continuous improvement
  • inspection readiness

Nice-to-have

  • working knowledge of multiple therapeutic areas
  • flexible and creative problem solver
  • proactive mindset
  • highly collaborative team player

Key Requirements

  • Bachelor’s degree in a scientific, allied health, or medical field
  • Minimum of 10 years of progressive experience
  • at least 5 years in a Clinical Quality Assurance role
  • Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP)
  • Broad clinical development experience across all phases (Phase I through BLA/NDA)
  • Proven experience developing and implementing risk-based clinical quality assurance programs
  • Demonstrated success leading clinical site and supplier audits
  • Willingness to travel up to 20%

Work Rights

Not specified

Tailored Resume

Cover Letter