Director, Quality Management Systems
Dyne Therapeutics
August 09, 2026
On-site
Waltham, MA
Operations
Role Summary / Location:
Director, Quality Management Systems (based in Waltham, MA)
Primary Responsibilities:
- Lead evolution of a commercial-ready, globally scalable Quality Management System (QMS) aligned with ICH Q10, FDA CFRs, and international regulatory standards.
- Ensure QMS processes are phase-appropriate, risk-based, and scalable.
- Establish and sustain proactive compliance to support continuous inspection readiness.
- Serve as subject matter expert and primary representative for assigned QMS areas during regulatory inspections and health authority interactions.
- Lead a risk-based internal audit program (planning, execution, follow-up).
- Identify systemic quality risks; ensure timely CAPA development, closure, and effectiveness checks.
- Build and mature a risk-based supplier quality program (qualification, monitoring, oversight).
- Oversee end-to-end product complaint management (intake, triage, investigation, escalation, trending) for scalability.
- Define, monitor, and report quality metrics/KPIs.
- Drive continuous improvement to enhance efficiency and robustness.
- Lead implementation/optimization/governance of eQMS platforms with validated systems and effective lifecycle management.
- Partner cross-functionally to embed quality into business processes and decision-making; communicate quality risks and tradeoffs.
Education & Requirements / Skills:
- Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred.
- 10+ years in biotech/pharma with GxPs exposure (GCP/GLP/GMP/GVP preferred).
- Demonstrated leadership with direct QMS/quality systems ownership.
- Deep knowledge of global regulations (FDA CFRs, ICH, EU Annex).
- Experience with eQMS platforms (e.g., Veeva eQMS, MasterControl) and learning management systems.
- Strong strategic + hands-on execution; manage multiple initiatives; strong risk judgment.
- Exceptional written/verbal communication; proactive, accountable, comfortable with autonomy.
Pay Range:
- $196,000 - $230,000 USD
Director, Quality Management Systems (based in Waltham, MA)
Primary Responsibilities:
- Lead evolution of a commercial-ready, globally scalable Quality Management System (QMS) aligned with ICH Q10, FDA CFRs, and international regulatory standards.
- Ensure QMS processes are phase-appropriate, risk-based, and scalable.
- Establish and sustain proactive compliance to support continuous inspection readiness.
- Serve as subject matter expert and primary representative for assigned QMS areas during regulatory inspections and health authority interactions.
- Lead a risk-based internal audit program (planning, execution, follow-up).
- Identify systemic quality risks; ensure timely CAPA development, closure, and effectiveness checks.
- Build and mature a risk-based supplier quality program (qualification, monitoring, oversight).
- Oversee end-to-end product complaint management (intake, triage, investigation, escalation, trending) for scalability.
- Define, monitor, and report quality metrics/KPIs.
- Drive continuous improvement to enhance efficiency and robustness.
- Lead implementation/optimization/governance of eQMS platforms with validated systems and effective lifecycle management.
- Partner cross-functionally to embed quality into business processes and decision-making; communicate quality risks and tradeoffs.
Education & Requirements / Skills:
- Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred.
- 10+ years in biotech/pharma with GxPs exposure (GCP/GLP/GMP/GVP preferred).
- Demonstrated leadership with direct QMS/quality systems ownership.
- Deep knowledge of global regulations (FDA CFRs, ICH, EU Annex).
- Experience with eQMS platforms (e.g., Veeva eQMS, MasterControl) and learning management systems.
- Strong strategic + hands-on execution; manage multiple initiatives; strong risk judgment.
- Exceptional written/verbal communication; proactive, accountable, comfortable with autonomy.
Pay Range:
- $196,000 - $230,000 USD