Senior Manager, GMP QA Operations

Department: 1320GL - QualityLocation: Waltham, MACompany 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 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 , and follow us on X, LinkedIn and Facebook.Role Summary: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. This is an onsite role based in Waltham, MA.Primary Responsibilities Include: Quality Operations ExecutionOversees release activities for Drug Substance (DS) and Drug Product (DP), including batch record review and disposition decisionsAssembles product disposition packages and Certificates of Conformance to support clinical trial supply and commercialization readinessEnsures timely and compliant execution of GMP QA activities across manufacturing and testing operationsExternal Manufacturing Oversight (CMOs)Represents GMP QA in interactions with CMOs, including governance meetings and operational discussionsEnsures contract manufacturing activities align with applicable regulatory requirements, industry standards, and internal expectationsMonitors vendor quality performance through defined metrics and ensures adherence to GMP requirementsQuality Systems & ComplianceLeads and supports GMP investigations, including root cause analysis, CAPA development, tracking, and effectiveness verificationPartners with internal teams to support change management activities impacting manufacturing and testingWorks within and enhances internal processes for batch record review and quality event management to ensure timely resolution of compliance issuesDevelops and tracks Quality Operations metrics (KPIs) for Management ReviewCross-Functional Collaboration & Continuous ImprovementCollaborates with Manufacturing, Quality Control, Supply Chain, Regulatory Affairs, and Project Management to ensure alignment on quality objectivesPartners with Quality Management Systems teams to drive consistency and continuous improvement across quality processesCommunicates quality risks, issues, and trends clearly to stakeholders to support informed decision-makingEducation and Skills Requirements: Bachelor’s degree in Engineering, Science, or relevant discipline; or Master’s Degree preferred6+ years’ experience in related cGMP environment (e.g., Medical Device, Diagnostic, Pharmaceutical, or other similar regulated industry) 4+ years of related work experience in Quality Assurance or closely related role within Medical Device, Diagnostic, Pharmaceutical, or other similar regulated industry, preferably with experience overseeing CMO/CDMO organizations. Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations. A proven track record of demonstrating good judgement & decision-making experience. Excellent organizational skills. Ability to concisely present quality events and the criticality to internal stakeholders. Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues. Experience with GXP QA systems, processes, and procedures such as documentation and record management, change control, deviations, investigations, training, and CAPA. A working knowledge of the therapeutic industry would be beneficial. Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources. Flexible and creative problem-solving skills; ability to challenge current processes, practices, and strategy and uncover alternative approaches, solutions, or methods. Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders and who is enthusiastic and willing to jump in to meet to all QA activities when required. Proficiency with software applications such as MS Office, SmartSheet, Veeva a plus #LI-OnsiteMA Pay Range$160,000—$195,000 USDThe 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.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.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.BACK | NEXT