Director, QA GMP Operations
Dyne Therapeutics
August 24, 2026
On-site
Waltham, MA
$188,000 - $230,000 USD yearly
Operations
Role Summary
- Director of QA GMP Operations responsible for management of GMP quality within external manufacturing operations globally and internal GMP operations for development and commercial programs.
- Oversees QA activities and ensures quality of deliverables; works with business stakeholders and internal Quality to advance programs in compliance.
- Onsite role based in Waltham, MA.
Primary Responsibilities
- Manage external quality operations supporting GMP manufacturing (clinical/commercial).
- Manage deviations, OOS and OOTs investigations (cGMP principles; ICH guidelines).
- Review batch records, analytical method reports, and technical reports including regulatory sections of IND/IMPD and BLA/MAAs.
- Support Tech Transfer and Process Validation.
- Disposition of GMP batches and interface with Qualified Person (QP).
- Lead change management for manufacturing/testing changes.
- Manage CDMO performance within Quality Agreement expectations and GMP compliance.
- Drive continuous improvement and inspection readiness.
- Ensure pre-approval inspection and commercial readiness activities are completed (CDMOs and internally).
- Adjudicate compliance discussions and negotiate corrective actions.
- Foster collaboration and engagement for quality outcomes and operational excellence.
Education/Experience/Requirements
- BA/BS minimum.
- 10+ years in GMP Quality Operations in clinical late stage and/or commercial biotech.
- Leadership experience managing cross-functional teams without direct authority.
- Experience with outsourcing/support models.
- Experience with GMP batch disposition and interfacing with QP.
- Strong communication, organization, collaboration, business management acumen, and ability to meet timelines.
- Embrace Dyne’s core values and culture.
MA Pay Range
- $188,000 - $230,000 USD.
- Director of QA GMP Operations responsible for management of GMP quality within external manufacturing operations globally and internal GMP operations for development and commercial programs.
- Oversees QA activities and ensures quality of deliverables; works with business stakeholders and internal Quality to advance programs in compliance.
- Onsite role based in Waltham, MA.
Primary Responsibilities
- Manage external quality operations supporting GMP manufacturing (clinical/commercial).
- Manage deviations, OOS and OOTs investigations (cGMP principles; ICH guidelines).
- Review batch records, analytical method reports, and technical reports including regulatory sections of IND/IMPD and BLA/MAAs.
- Support Tech Transfer and Process Validation.
- Disposition of GMP batches and interface with Qualified Person (QP).
- Lead change management for manufacturing/testing changes.
- Manage CDMO performance within Quality Agreement expectations and GMP compliance.
- Drive continuous improvement and inspection readiness.
- Ensure pre-approval inspection and commercial readiness activities are completed (CDMOs and internally).
- Adjudicate compliance discussions and negotiate corrective actions.
- Foster collaboration and engagement for quality outcomes and operational excellence.
Education/Experience/Requirements
- BA/BS minimum.
- 10+ years in GMP Quality Operations in clinical late stage and/or commercial biotech.
- Leadership experience managing cross-functional teams without direct authority.
- Experience with outsourcing/support models.
- Experience with GMP batch disposition and interfacing with QP.
- Strong communication, organization, collaboration, business management acumen, and ability to meet timelines.
- Embrace Dyne’s core values and culture.
MA Pay Range
- $188,000 - $230,000 USD.