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About the role
<div class="content-intro"><h3>Company Overview:</h3>
<p>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 a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at <a href="https://www.dyne-tx.com/">https://www.dyne-tx.com/</a>, and follow us on <a href="https://x.com/dyne_tx">X</a>, <a href="https://www.linkedin.com/company/dynetx/">LinkedIn</a> and <a href="https://www.facebook.com/DyneTherapeutic/">Facebook</a>.</p></div><p><strong>Role Summary:</strong></p>
<p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="auto"><span data-ccp-parastyle="Body Text">The Director, Quality </span><span data-ccp-parastyle="Body Text">Management</span><span data-ccp-parastyle="Body Text"> </span><span data-ccp-parastyle="Body Text">Systems is a </span><span data-ccp-parastyle="Body Text">quality</span><span data-ccp-parastyle="Body Text"> </span><span data-ccp-parastyle="Body Text">leader responsible for </span><span data-ccp-parastyle="Body Text">designing, scaling, and advancing a</span><span data-ccp-parastyle="Body Text"> </span><span data-ccp-parastyle="Body Text">global </span><span data-ccp-parastyle="Body Text">Quality Management System (QMS)</span><span data-ccp-parastyle="Body Text"> that supports Dyne’s transition to commercial operations.</span><span data-ccp-parastyle="Body Text"> </span></span><span data-contrast="none"><span data-ccp-parastyle="Body Text">This role </span><span data-ccp-parastyle="Body Text">i</span><span data-ccp-parastyle="Body Text">s responsible for</span><span data-ccp-parastyle="Body Text"> </span><span data-ccp-parastyle="Body Text">key elements of the QMS including </span><span data-ccp-parastyle="Body Text">s</span><span data-ccp-parastyle="Body Text">upplier </span><span data-ccp-parastyle="Body Text">q</span><span data-ccp-parastyle="Body Text">uality, </span><span data-ccp-parastyle="Body Text">a</span><span data-ccp-parastyle="Body Text">udit</span><span data-ccp-parastyle="Body Text">s,</span><span data-ccp-parastyle="Body Text"> </span><span data-ccp-parastyle="Body Text">and </span><span data-ccp-parastyle="Body Text">p</span><span data-ccp-parastyle="Body Text">roduct </span><span data-ccp-parastyle="Body Text">c</span><span data-ccp-parastyle="Body Text">omplaint</span><span data-ccp-parastyle="Body Text"> management</span><span data-ccp-parastyle="Body Text"> </span><span data-ccp-parastyle="Body Text">p</span><span data-ccp-parastyle="Body Text">rograms</span><span data-ccp-parastyle="Body Text">, ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations</span><span data-ccp-parastyle="Body Text">.</span><span data-ccp-parastyle="Body Text"> </span></span><span data-contrast="auto"><span data-ccp-parastyle="Body Text">The </span><span data-ccp-parastyle="Body Text">D</span><span data-ccp-parastyle="Body Text">irector will partner cross-functionally</span><span data-ccp-parastyle="Body Text"> to </span><span data-ccp-parastyle="Body Text">embed quality as a strategic enabler of business performance, ensuring systems </span><span data-ccp-parastyle="Body Text">are fit</span><span data-ccp-parastyle="Body Text">-for-purpose, inspection-ready, scalable</span><span data-ccp-parastyle="Body Text">, and efficient</span><span data-ccp-parastyle="Body Text"> as the organization grows. </span><span data-ccp-parastyle="Body Text">This is a hands-on leadership role that requires both strategic</span><span data-ccp-parastyle="Body Text"> vision and operational </span><span data-ccp-parastyle="Body Text">execution</span><span data-ccp-parastyle="Body Text">.</span></span><span data-ccp-props="{"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></p>
<p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="auto"><span data-ccp-parastyle="Body" data-ccp-parastyle-defn="{"ObjectId":"b669530d-9cee-5fd4-8da3-4cdbed7bfaa2|1","ClassId":1073872969,"Properties":[469775450,"Body",201340122,"2",134233614,"true",469778129,"Body",335572020,"1",469777841,"Helvetica",469777842,"Helvetica",469777843,"Helvetica",469777844,"Helvetica",469769226,"Helvetica",335551500,"0",268442635,"22"]}">This role is based in Waltham, MA</span><span data-ccp-parastyle="Body">.</span></span> <br> <br><strong><span data-contrast="none"><span data-ccp-parastyle="Body">Primary Responsibilities</span><span data-ccp-parastyle="Body"> Include</span><span data-ccp-parastyle="Body">:</span></span></strong><span data-ccp-props="{"335559739":120}"> </span></p>
<p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><em><span data-contrast="auto">QMS Strategy, Compliance & Inspection Readiness</span></em><span data-ccp-props="{"201341983":0,"335559685":0,"335559739":160,"335559740":278,"335572072":0,"335572073":4278190080,"335572076":0,"335572077":4278190080,"335572080":0,"335572081":4278190080,"335572084":0,"335572085":4278190080,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></p>
<ul>
<li><span data-contrast="auto">Leads the evolution of the QMS into a commercial-ready, globally scalable system aligned with ICH Q10, FDA CFRs, and international regulatory standards</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Ensures QMS processes are phase-appropriate, risk-based, and designed to scale with organizational growth</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Establishes and sustains a proactive compliance model that supports continuous inspection readiness</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Serves as a subject matter expert and primary representative for assigned QMS areas during regulatory inspections and health authority interactions</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
</ul>
<p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><em><span data-contrast="auto">Core QMS Program Ownership</span></em><span data-ccp-props="{"134233117":false,"201341983":0,"335551550":0,"335551620":0,"335559685":0,"335559738":240,"335559740":300}"> </span></p>
<ul>
<li><span data-contrast="auto">Leads a risk-based internal audit program, including planning, execution, and follow-up across functions</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Identifies systemic quality risks and ensures timely CAPA development, closure, and effectiveness checks</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Builds and matures a risk-based supplier quality program, including supplier qualification, monitoring, and ongoing oversight</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Oversees the end-to-end product complaint management lifecycle, including intake, triage, investigation, escalation, and trending, ensuring scalability for commercial distribution</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
</ul>
<p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><em><span data-contrast="auto">Operational Excellence & Systems Enablement</span></em><span data-ccp-props="{"134233117":false,"201341983":0,"335551550":0,"335551620":0,"335559685":0,"335559738":240,"335559740":300}"> </span></p>
<ul>
<li><span data-contrast="auto">Defines, monitors, and reports quality metrics and KPIs to assess system health, compliance risk, and performance trends</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Drives continuous improvement initiatives to enhance efficiency, reduce risk, and strengthen QMS robustness</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Leads the implementation, optimization, and governance of eQMS platforms, ensuring validated systems, strong user adoption, and effective lifecycle management</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
</ul>
<p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><em><span data-contrast="auto">Cross-Functional Leadership & Quality Culture</span></em><span data-ccp-props="{"134233117":false,"201341983":0,"335551550":0,"335551620":0,"335559685":0,"335559738":240,"335559740":300}"> </span></p>
<ul>
<li><span data-contrast="auto">Partners with cross-functional stakeholders to embed quality into business processes and decision-making</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Communicates quality risks, dependencies, and tradeoffs with clarity and urgency, influencing outcomes without direct authority</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Contributes to building a high-performing quality organization and models a culture of accountability, transparency, and continuous improvement</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":0,"335551620":0,"335559738":0,"335559739":0,"335559740":300}"> </span></li>
</ul>
<p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":278,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span><strong><span data-contrast="none"><span data-ccp-parastyle="Body">Education and Skills Requirements:</span></span></strong><span data-ccp-props="{"201341983":0,"335559739":160,"335559740":278,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></p>
<ul>
<li><span data-contrast="auto">Bachelor’s degree in a scientific discipline or Quality Systems Management; advanced degree preferred</span><span data-ccp-props="{"201341983":2,"335559740":300,"335572072":0,"335572073":4278190080,"335572076":0,"335572077":4278190080,"335572080":0,"335572081":4278190080,"335572084":0,"335572085":4278190080,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li>
<li><span data-contrast="auto">10+ years of experience in biotechnology or pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP, GVP preferred)</span><span data-ccp-props="{"201341983":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Demonstrated leadership experience with direct ownership of QMS and quality systems</span><span data-ccp-props="{"201341983":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Deep understanding of global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements</span><span data-ccp-props="{"201341983":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Proven experience implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Learning Management Systems</span><span data-ccp-props="{"201341983":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Strong strategic and operational capability, balancing vision-setting with hands-on execution</span><span data-ccp-props="{"201341983":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Proven ability to manage multiple complex initiatives in a fast-paced, dynamic environment</span><span data-ccp-props="{"201341983":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Strong judgment and risk management skills, balancing compliance, science, and business needs</span><span data-ccp-props="{"201341983":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Exceptional written and verbal communication skills with the ability to influence senior and cross-functional stakeholders</span><span data-ccp-props="{"201341983":0,"335559740":300}"> </span></li>
<li><span data-contrast="auto">Highly proactive, accountable, and comfortable operating with a high degree of autonomy</span><span data-ccp-props="{"201341983":0,"335559740":300}"> </span></li>
</ul>
<p>#LI-Onsite</p><div class="content-pay-transparency"><div class="pay-input"><div class="title">MA Pay Range</div><div class="pay-range"><span>$196,000</span><span class="divider">—</span><span>$230,000 USD</span></div></div></div><div class="content-conclusion"><p> </p>
<p>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.</p>
<p>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.</p>
<p class="Body"><em><span style="font-family: 'Arial',sans-serif; color: #626262;">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.</span></em></p></div>
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