Director, QA GMP Operations

<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-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="auto">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. </span><span data-ccp-props="{}"> </span></p> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-ccp-props="{}">This is an onsite role based in Waltham, MA.</span></p> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"> <br><strong><span data-contrast="none"><span data-ccp-parastyle="Normal (Web)">Primary Responsibilities</span><span data-ccp-parastyle="Normal (Web)"> Include</span><span data-ccp-parastyle="Normal (Web)">:</span></span></strong><span data-ccp-props="{"134233117":false,"134233118":true,"335557856":16777215,"335559738":0,"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">Management of external quality operations in support of GMP manufacturing (clinical and commercial) activities.</span><span data-ccp-props="{"201341983":0,"335559685":630,"335559740":259,"335559991":450,"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,"469777462":[360,630],"469777927":[0,0],"469777928":[0,8],"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="auto">Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines.</span><span data-ccp-props="{"201341983":0,"335559685":630,"335559740":259,"335559991":450,"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,"469777462":[360,630],"469777927":[0,0],"469777928":[0,8],"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="auto">Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs.</span><span data-ccp-props="{"201341983":0,"335559685":630,"335559740":259,"335559991":450,"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,"469777462":[360,630],"469777927":[0,0],"469777928":[0,8],"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="auto">QA support of Tech Transfer and Process Validation activities.</span><span data-ccp-props="{"201341983":0,"335559685":630,"335559740":259,"335559991":450,"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,"469777462":[360,630],"469777927":[0,0],"469777928":[0,8],"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="auto">Disposition of GMP batches and interfacing with the Qualified Person (QP).</span><span data-ccp-props="{"201341983":0,"335559685":630,"335559740":259,"335559991":450,"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,"469777462":[360,630],"469777927":[0,0],"469777928":[0,8],"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="auto">Change management to ensure proper evaluation of manufacturing and testing related changes by Quality, Regulatory, and Subject Matter Experts.</span><span data-ccp-props="{"201341983":0,"335559685":630,"335559740":259,"335559991":450,"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,"469777462":[360,630],"469777927":[0,0],"469777928":[0,8],"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="auto">Manage CDMO performance within Quality Agreement expectations and GMP compliance. </span><span data-ccp-props="{"201341983":0,"335559685":630,"335559740":259,"335559991":450,"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,"469777462":[360,630],"469777927":[0,0],"469777928":[0,8],"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="auto">Drive continuous improvement and inspection readiness. </span><span data-ccp-props="{"201341983":0,"335559685":630,"335559740":259,"335559991":450,"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,"469777462":[360,630],"469777927":[0,0],"469777928":[0,8],"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="auto">Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are completed at the CDMOs and internally. </span><span data-ccp-props="{"201341983":0,"335559685":630,"335559740":259,"335559991":450,"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,"469777462":[360,630],"469777927":[0,0],"469777928":[0,8],"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="auto">Adjudicate on compliance discussions and negotiate any required corrective actions.</span><span data-ccp-props="{"201341983":0,"335559685":630,"335559740":259,"335559991":450,"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,"469777462":[360,630],"469777927":[0,0],"469777928":[0,8],"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> <li><span data-contrast="auto">Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence.</span><span data-ccp-props="{"201341983":0,"335559685":630,"335559740":259,"335559991":450,"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,"469777462":[360,630],"469777927":[0,0],"469777928":[0,8],"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></li> </ul> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><strong><span data-contrast="none"><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"]}">Education and Skills Requirements:</span></span></strong><span data-ccp-props="{"335559739":120}"> </span></p> <ul> <li><span data-contrast="auto">Minimum of a BA/BS degree</span><span data-ccp-props="{"335559685":540,"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></li> <li><span data-contrast="auto">Minimum of 10+ years of experience in GMP Quality Operations in a </span><span data-contrast="auto">clinical late stage and/or commercial biotechnology company</span><span data-ccp-props="{"335559685":540,"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></li> <li><span data-contrast="auto">Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority</span><span data-ccp-props="{"134233117":true,"134233118":true,"335559685":540,"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></li> <li><span data-contrast="auto">Experience implementing and utilizing various outsourcing and support models</span><span data-ccp-props="{"134233117":true,"134233118":true,"335559685":540,"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></li> <li><span data-contrast="auto">Experience with disposition of product batches and interfacing with a Qualified Person (QP)</span><span data-ccp-props="{"335559685":540}"> </span></li> <li><span data-contrast="auto">Excellent written and oral communication skills, including well-developed presentation skills</span><span data-ccp-props="{"134233117":true,"134233118":true,"335559685":540,"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></li> <li><span data-contrast="auto">Excellent organizational skills and ability to manage multiple priorities</span><span data-ccp-props="{"134233117":true,"134233118":true,"335559685":540,"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></li> <li><span data-contrast="auto">Strong collaboration and interpersonal skills to effectively interact with internal or external stakeholders at all levels in the organization</span><span data-ccp-props="{"134233117":true,"134233118":true,"335559685":540,"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></li> <li><span data-contrast="auto">General business management knowledge to assess the impact of project decisions on financial and corporate objectives</span><span data-ccp-props="{"134233117":true,"134233118":true,"335559685":540,"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></li> <li><span data-contrast="auto">Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities</span><span data-ccp-props="{"335559685":540,"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></li> <li><span data-contrast="auto">Embrace Dyne’s core values and culture</span><span data-ccp-props="{"335559685":540,"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></li> </ul> <p> </p> <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>$188,000</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>