New · posted Oct 15
Dyne Therapeutics · Biotechnology
Associate Director, Quality Management Systems
- Waltham, MA
- On-site
- Full-time
- Director
Open until filled
The role
The Associate Director, Quality Management Systems is a key member of the quality team responsible for designing, scaling, and advancing a global Quality Management System (QMS) that supports Dyne’s transition to commercial operations. This role is responsible for key elements of the QMS including document control, records management and training ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations. The Associate Director partners cross-functionally to embed quality as a strategic enabler of business performance, ensuring systems are fit-for-purpose, inspection-ready, scalable, and efficient as the organization grows. This is a hands-on role that requires both strategic vision and operational execution.
This role is based in Waltham, MA.
Primary Responsibilities Include:
QMS Strategy, Compliance & Inspection Readiness
- Leads the evolution of the QMS into a commercial-ready, globally scalable system aligned with ICH Q10, FDA CFRs, and international regulatory standards
- Ensures QMS processes are phase-appropriate, risk-based, and designed to scale with organizational growth
- Establishes and sustains a proactive compliance model that supports continuous inspection readiness
- Serves as a subject matter expert and primary representative for assigned QMS areas during regulatory inspections and health authority interactions
- Provides strategic and operational leadership for GxP documentation and training programs, ensuring effective use and governance of the eDMS and LMS in support of the quality management system
Core QMS Program Ownership
- Oversees the end-to-end lifecycle management of quality documents, including policies, SOPs, and related controlled records, ensuring consistency, accuracy, and compliance with applicable regulations that achieves inspection readiness
- Drives and manage high-volume document authoring, revision, and implementation – often under accelerated timelines
- Leads the planning, deployment, and governance of role-based training curriculum across functions
- Leads the design and implementation of learning programs (refresher training, cross-training, etc.)
- Manages the day-to-day delivery of programs to ensure consistent quality and alignment to employees and their learning goals
- Drives development and review of engaging learning materials/ assessments to support learning programs utilizing multiple delivery methods
- Leads technical sessions as needed to scale eDMS/LMS capabilities
Operational Excellence & Systems Enablement
- Defines, monitors, and reports quality metrics and KPIs to assess system health, compliance risk, and performance trends
- Drives continuous improvement initiatives to enhance efficiency, reduce risk, and strengthen QMS robustness
- Leads the implementation, optimization, and governance of eQMS platforms, ensuring validated systems, strong user adoption, and effective lifecycle management
What you need
Education and Skills Requirements
- Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred
- 8+ years of experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP, GVP preferred)
- Demonstrated experience with direct ownership of QMS and quality systems
- Deep understanding of global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements
- Proven experience implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Learning Management Systems
- Strong strategic and operational capability, balancing vision-setting with hands-on execution
- Proven ability to manage multiple complex initiatives in a fast-paced, dynamic environment
- Strong judgment and risk management skills, balancing compliance, science, and business needs
- Exceptional written and verbal communication skills with the ability to influence senior and cross-functional stakeholders
- Highly proactive, accountable, and comfortable operating with a high degree of autonomy
MA Pay Range
$160,000—$195,000 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.
Pay
$160,000 – $195,000 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.
Cross-Functional Leadership & Quality Culture
- Partners with cross-functional stakeholders to embed quality into business processes and decision-making
- Communicates quality risks, dependencies, and tradeoffs with clarity and urgency, influencing outcomes without direct authority
- Contributes to building a high-performing quality organization and models a culture of accountability, transparency, and continuous improvement
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 15% below 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 | $160,000 | — | $195,000 |
| 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 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk10
- GMP and compliance8
- Collaboration and leadership8
- Documentation and SOPs5
- Lab testing and methods1
- Validation and qualification1
- Regulatory submissions1
- Data and digital systems1
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
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
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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Associate Director, Quality Management Systems at Dyne Therapeutics
Open until filled. $160K–$195K a year, employer provided.