Senior Director, Pharmacovigilance Quality Assurance

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><span data-contrast="auto"><span data-ccp-parastyle="Body Text">The Senior Director, Pharmacovigilance Quality Assurance (PVQA) leads the strategy, governance, and execution of Dyne’s global pharmacovigilance quality framework. This role sets the direction for PV quality systems and ensures scalable, inspection-ready operations that support high-quality regulatory submissions and continuous patient safety assurance across the portfolio.</span></span><span data-ccp-props="{"335559685":90,"335559731":0,"335559738":1,"335559991":360}"> </span></p> <p><span data-contrast="auto"><span data-ccp-parastyle="Body Text">This leader designs and evolves Dyne’s Pharmacovigilance Quality Management System, integrating global standards with business needs across clinical and future commercial programs. They serve as a senior advisor on PV quality risks, regulatory expectations, vendor oversight, and </span><span data-ccp-parastyle="Body Text">inspection</span><span data-ccp-parastyle="Body Text"> readiness while fostering a culture of quality, accountability, and continuous improvement.</span></span><span data-ccp-props="{"335559685":90,"335559731":0,"335559738":1,"335559991":360}"> </span></p> <p><span data-contrast="auto"><span data-ccp-parastyle="Body Text">This</span> <span data-ccp-parastyle="Body Text">role</span> <span data-ccp-parastyle="Body Text">is</span> <span data-ccp-parastyle="Body Text">based</span> <span data-ccp-parastyle="Body Text">in</span> <span data-ccp-parastyle="Body Text">Waltham,</span> <span data-ccp-parastyle="Body Text">MA.</span></span><span data-ccp-props="{"335559685":90,"335559731":0,"335559738":1,"335559991":360}"> </span></p> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="heading 1">Primary</span><span data-ccp-parastyle="heading 1"> </span><span data-ccp-parastyle="heading 1">Responsibilities</span><span data-ccp-parastyle="heading 1"> </span><span data-ccp-parastyle="heading 1">Include</span></span></strong><span data-ccp-props="{"335559685":101,"335559738":253}"> </span></p> <p><em><span data-contrast="auto"><span data-ccp-parastyle="heading 1">Enterprise Strategy & Leadership</span></span></em><span data-ccp-props="{"335559685":101,"335559738":253}"> </span></p> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="heading 1">Define and own the global PVQA strategy, aligned </span><span data-ccp-parastyle="heading 1">to</span><span data-ccp-parastyle="heading 1"> Dyne’s development and commercialization roadmap.</span></span><span data-ccp-props="{"335559685":720,"335559738":253,"335559991":360}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="heading 1">Serve as Dyne’s subject matter expert on PV quality, advising senior leaders on regulatory expectations, compliance risks, inspection trends, and emerging best practices.</span></span><span data-ccp-props="{"335559685":720,"335559738":253,"335559991":360}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="heading 1">Build, lead, and develop a high-performing PVQA organization, including capability building, mentorship, succession planning, and talent development.</span></span><span data-ccp-props="{"335559685":720,"335559738":253,"335559991":360}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="heading…