Dyne Therapeutics · 3 weeks ago
Director, QA GMP Operations
Waltham, MA
Full-time
Onsite
Director/Executive
$188K/yr - $230K/yr
10+ years expDyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The Director of QA GMP Operations is responsible for managing GMP quality within external manufacturing operations globally and internal GMP operations, ensuring compliance and quality deliverables.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Management of external quality operations in support of GMP manufacturing (clinical and commercial) activities
Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines
Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs
QA support of Tech Transfer and Process Validation activities
Disposition of GMP batches and interfacing with the Qualified Person (QP)
Change management to ensure proper evaluation of manufacturing and testing related changes by Quality, Regulatory, and Subject Matter Experts
Manage CDMO performance within Quality Agreement expectations and GMP compliance
Drive continuous improvement and inspection readiness
Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are completed at the CDMOs and internally
Adjudicate on compliance discussions and negotiate any required corrective actions
Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence
Qualification
Required
Minimum of a BA/BS degree
Minimum of 10+ years of experience in GMP Quality Operations in a clinical late stage and/or commercial biotechnology company
Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority
Experience implementing and utilizing various outsourcing and support models
Experience with disposition of product batches and interfacing with a Qualified Person (QP)
Excellent written and oral communication skills, including well-developed presentation skills
Excellent organizational skills and ability to manage multiple priorities
Strong collaboration and interpersonal skills to effectively interact with internal or external stakeholders at all levels in the organization
General business management knowledge to assess the impact of project decisions on financial and corporate objectives
Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities
Embrace Dyne's core values and culture
Company
Dyne Therapeutics
Dyne Therapeutics is a developer of targeted therapies intended for serious muscle diseases.
51-200 employees
H1B Sponsorship
Dyne Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (7)
2023 (1)
2022 (3)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Hercules CapitalAtlas Venture
2025-12-09Post Ipo Equity· $402.5M
2025-06-30Post Ipo Equity· $230M
2025-06-30Post Ipo Debt· $100M
Leadership Team
John Cox
Chief Executive Officer
Recent News
2026-01-11
2026-01-07
2025-12-24
Company data provided by crunchbase