Senior QA Ops Lead, External Mfg & Compliance

Dyne Therapeutics; Waltham (MA); On-site; USD 160,000 - 195,000; Full time

Job summary

Dyne Therapeutics is seeking an Associate Director, QA Operations in Waltham, MA to lead QA activities for external manufacturing and testing programs. You will drive GMP quality systems, risk mitigation, and cross-functional collaboration to ensure compliance.

The role requires 8+ years in cGMP environments, strong regulatory knowledge (FDA/EMA), and experience overseeing CMOs/CDMOs. You will mentor teams, improve batch release processes, and support regulatory submissions.

Qualifications

• Bachelor’s degree in Engineering, Science, or related discipline.
• 8+ years’ experience in a cGMP environment in regulated industry.
• 5+ years QA or related role, preferably overseeing CMO/CDMO.
• Knowledge of FDA and EMA regulations.
• Strong judgment, organizational and communication skills.
• Experience with GXP QA systems and CAPA processes.
• Ability to present quality events clearly to stakeholders.
• Collaborative team player with proactive QA leadership.
• Proficiency with MS Office, Smartsheet, and Veeva is a plus.

Responsibilities

• QA lead for external manufacturing and testing teams.
• Represent QA Operations with CMOs and external partners.
• Ensure manufacturing aligns with regulatory requirements.
• Participate in CMO Quality Agreement review.
• Oversee release activities for DSIs, DS, and DP.
• Lead or support investigations and CAPA tracking.
• Support change management and product labeling input.
• Contribute to regulatory submissions and IND-related correspondence.
• Develop and maintain Quality Systems and KPIs.
• Mentor and train QA team; communicate risks to stakeholders.

Skills

QA Operations leadership

GXP / cGMP knowledge

Regulatory compliance (FDA & EMA)

Change management

CAPA investigations

Root cause analysis

Batch record review

Documentation control

Mentorship/training

MS Office / Smartsheet / Veeva

Education

Bachelor’s degree in Engineering, Science, or related discipline

Master’s Degree preferred

Tools

MS Office

Smartsheet

Veeva

Job description

Dyne Therapeutics is seeking an Associate Director, QA Operations in Waltham, MA to lead QA activities for external manufacturing and testing programs. You will drive GMP quality systems, risk mitigation, and cross-functional collaboration to ensure compliance.

The role requires 8+ years in cGMP environments, strong regulatory knowledge (FDA/EMA), and experience overseeing CMOs/CDMOs. You will mentor teams, improve batch release processes, and support regulatory submissions.