Director, QA GMP Operations

Company Overview: 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 . Role Summary: 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. This is an onsite role based in Waltham, MA. Primary Responsibilities Include : Management of external quality operations in support of GMP manufacturing (clinical and commercial) activities. Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines. Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs. QA support of Tech Transfer and Process Validation activities. Disposition of GMP batches and interfacing with the Qualified Person (QP). Change management to ensure proper evaluation of manufacturing and testing related changes by Quality, Regulatory, and Subject Matter Experts. Manage CDMO performance within Quality Agreement expectations and GMP compliance. Drive continuous improvement and inspection readiness. <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],"469789