New · posted Oct 15
Dyne Therapeutics · Biotechnology
Senior Director, Quality Control
- Waltham, MA
- On-site
- Full-time
- Director
Open until filled
The role
The Senior Director, Quality Control leads the strategy and execution of Quality Control activities that support clinical and commercial manufacturing, pipeline advancement, and product lifecycle management. This role ensures global GMP compliance, inspection readiness, and robust analytical support across external testing laboratories, including release and stability testing.
The Senior Director partners closely with contract manufacturing and testing organizations and collaborates across Analytical and Process Development, Manufacturing, Quality Assurance, Supply Chain, Regulatory Affairs, and Project Management to advance quality and business objectives.
This position is based in Waltham, MA and is not eligible for remote work.
What you need
Education and Skills Requirements
- Bachelor’s degree in biology, analytical chemistry, biochemistry, or a related field.
- Advanced degree in chemistry, analytical chemistry, or a related discipline is preferred.
- 15+ years of experience in Analytical Development and Quality Control, or equivalent experience, including significant leadership of people or a function.
- Strong GMP Quality Control background, including experience with compendial and product-specific assays for antibodies and small molecules.
- Strong knowledge of current Good Manufacturing Practices and applicable International Council for Harmonisation, U.S. Food and Drug Administration, and European Union regulations.
- Demonstrated experience overseeing contract testing laboratories, analytical method lifecycle activities, release and stability programs, and inspection readiness.
- Demonstrated experience supporting regulatory submissions and inspections, including the preparation and review of analytical Chemistry, Manufacturing, and Controls content.
- Experience establishing and maintaining drug substance and drug product specifications, stability programs, reference standard programs, and laboratory compliance systems.
- Strong understanding of data integrity requirements, change controls, corrective and preventive actions, and out-of-specification and out-of-trend investigations.
- Demonstrated ability to set functional direction, manage interdependencies, influence senior stakeholders, and translate strategy into execution.
- Proven ability to establish productive relationships and negotiate effectively with contract laboratories, manufacturing organizations, and other external partners.
- Excellent interpersonal, organizational, negotiation, and written and verbal communication skills.
- Ability to operate effectively in a highly matrixed, fast-paced, and evolving environment.
- Sound judgment and the ability to make decisions involving complex technical, compliance, operational, and organizational considerations.
MA Pay Range
$240,000—$285,000 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
QC Strategy, Compliance, and Regulatory Readiness
- Define and execute the Quality Control strategy in alignment with quality and business objectives.
- Ensure contract testing laboratories meet global GMP requirements and maintain inspection readiness.
- Represent Quality Control during regulatory inspections.
- Author, review, and approve analytical Chemistry, Manufacturing, and Controls sections of Investigational New Drug applications, Biologics License Applications, and Marketing Authorization Applications.
- Evaluate and implement effective tools for analytical data review, statistical analysis, stability assessment, and expiry assignment.
- Lead internal Specification and Stability Review Boards and facilitate clear, timely, and risk-based decisions.
Technical and Operational Leadership
- Lead the authoring, review, and approval of analytical method transfers, qualifications, and validations.
- Oversee external testing laboratory operations, release and stability testing, and the issuance of Certificates of Analysis.
- Review environmental monitoring, sterility, bioburden, and endotoxin data and participate in related reviews and investigations.
- Lead the establishment and revision of drug substance and drug product specifications, including the development of appropriate scientific and regulatory rationale.
- Lead Quality Control compliance activities, including change controls, corrective and preventive actions, and data integrity initiatives.
- Lead out-of-specification and out-of-trend investigations and ensure appropriate root-cause analysis, corrective actions, and timely resolution.
- Oversee the reference standard program across external testing vendors.
Performance, Analytics, and Vendor Partnership
- Build Quality Control capabilities in stability data analysis, biological assays, and statistical analysis to support evolving portfolio and business needs.
- Analyze laboratory performance and quality metrics and present findings, risks, trends, and recommendations in internal and vendor governance forums.
- Partner with contract manufacturing and testing organizations to align expectations, resolve complex issues, and drive reliable execution.
- Establish clear performance expectations for external laboratories and monitor execution against quality, compliance, and operational objectives.
- Apply sound judgment, situational awareness, collaboration, and negotiation skills to influence outcomes across a highly matrixed environment.
- Collaborate with internal stakeholders to anticipate analytical and Quality Control requirements for clinical development, commercialization, and lifecycle management.
People and Organizational Leadership
- Build and strengthen technical Quality Control capabilities to support corporate goals, pipeline advancement, and future growth.
- Recruit, coach, and mentor team members while supporting professional development and career growth.
- Establish clear priorities, promote accountability, and ensure resources are aligned with functional and organizational objectives.
- Foster an inclusive, collaborative, and high-performing team culture focused on quality, continuous improvement, and results.
- Empower team members and leaders to exercise sound judgment, take ownership of outcomes, and work effectively across functions.
- Promote transparent communication, constructive feedback, and effective collaboration with internal and external partners.
Pay
$240,000 – $285,000 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 32% above the US median for Quality Control roles at this level.
This roleEmployer provided
Director roles in Massachusetts7 roles publishing pay
Director roles in the US25 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $240,000 | — | $285,000 |
| Massachusetts (middle half) | $207,000 | $220,000 | $243,750 |
| All US (middle half) | $186,000 | $198,500 | $240,000 |
This role: Dyne Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 275 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Dyne Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 46 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods23
- Collaboration and leadership16
- GMP and compliance11
- Investigations and CAPA4
- Quality systems and risk4
- Data and digital systems2
- Documentation and SOPs1
- Validation and qualification1
- Regulatory submissions1
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 data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License 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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Senior Director, Quality Control at Dyne Therapeutics
Open until filled. $240K–$285K a year, employer provided.