Senior Manager, GMP QA Operations

About this 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"></p> <div> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol">The Senior Manager, GMP QA Operations oversees quality activities associated with contract manufacturing organizations (CMOs) and ensures compliance with FDA and global GMP regulations. Leads tactical GMP QA operations supporting manufacturing, testing, deviation investigations, and CAPA implementation to enable compliant product disposition for clinical development and future commercialization. Partners cross-functionally to ensure quality systems are effectively applied and continuously improved to support Dyne Therapeutics’ pipeline. </div> </div> <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"><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> <p></p> <p></p> <div> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol"><em>Quality Operations Execution</em></div> <ul> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Oversees release activities for Drug Substance (DS) and Drug Product (DP), including batch record review and disposition decisions</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Assembles product disposition packages and Certificates of Conformance to support clinical trial supply and commercialization readiness</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Ensures timely and compliant execution of GMP QA activities across manufacturing and testing operations</li> </ul> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol"><em>External Manufacturing Oversight (CMOs)</em></div> <ul> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Represents GMP QA in interactions with CMOs, including governance meetings and operational discussions</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Ensures contract manufacturing activities align with applicable regulatory requirements, industry standards, and internal expectations</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Monitors vendor quality performance through defined metrics and ensures adherence to GMP requirements</li> </ul> <div class="paragraph-in-scc-markdown-text ___1ngh792 ftgm304 f1iaxwol"><em>Quality Systems & Compliance</em></div> <ul> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Leads and supports GMP investigations, including root cause analysis, CAPA development, tracking, and effectiveness verification</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Partners with internal teams to support change management activities impacting manufacturing and testing</li> <li class="___ccc16d0 fje8fi8 f1ng9h0j f1bwykku f18jd3zf">Works within and enhances internal processes for…