New · posted Oct 15
Dyne Therapeutics · Biotechnology
Director, QA GMP Operations
- Waltham, MA
- On-site
- Full-time
- Director
Open until filled
The role
The Director of QA GMP Operations is responsible for management of GMP quality within our external manufacturing operations globally and internal GMP operations for development and commercial programs. The Director will also work closely with internal business stakeholders as well as internal Quality function to deliver outcomes to advance programs within compliance. The Director is responsible for oversight of QA activities and ensuring the quality of deliverables within the role's purview.
This is an onsite role based in Waltham, MA.
What you need
Education and Skills Requirements
- 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
MA Pay Range
$188,000—$230,000 USD
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
What you'll do
Primary Responsibilities Include
- 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.
Pay
$188,000 – $230,000 a year
Employer providedWhere you'll work
Waltham, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Waltham, MAFrom the posting
About Dyne Therapeutics
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Equal opportunity, accessibility and legal noticesDyne Therapeutics's statements, word for word
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in Massachusetts33 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $188,000 | — | $230,000 |
| Massachusetts (middle half) | $186,000 | $204,500 | $231,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
This role: Dyne Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Dyne Therapeutics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance9
- Collaboration and leadership6
- Lab testing and methods2
- Documentation and SOPs1
- Investigations and CAPA1
- Validation and qualification1
- Regulatory submissions1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
Company hiring pulse
Dyne Therapeutics on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 2
- Locations
By discipline
- Quality3 60%
- Regulatory2 40%
By level
- Director5 100%
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Director, QA GMP Operations at Dyne Therapeutics
Open until filled. $188K–$230K a year, employer provided.