Dyne Therapeutics
Senior Manager, GMP QA Operations
Waltham, MA · Senior
Sponsorship not specified$160k-$195kDetected 16 days ago
Project ManagementSupply ChainGMPFDA RegulatoryMedical DevicesAnimal StudiesCommunicationCollaborationProblem SolvingMicrosoft OfficeGxPRegulatory Affairs
About the role
- Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases.
- 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.
- Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Responsibilities
- Assembles product disposition packages and Certificates of Conformance to support clinical trial supply and commercialization readiness
- Leads and supports GMP investigations, including root cause analysis, CAPA development, tracking, and effectiveness verification
- Partners with internal teams to support change management activities impacting manufacturing and testing
- Develops and tracks Quality Operations metrics (KPIs) for Management Review
- Collaborates with Manufacturing, Quality Control, Supply Chain, Regulatory Affairs, and Project Management to ensure alignment on quality objectives
- Partners with Quality Management Systems teams to drive consistency and continuous improvement across quality processes
- Communicates quality risks, issues, and trends clearly to stakeholders to support informed decision-making
Requirements
- A proven track record of demonstrating good judgement & decision-making experience.
- 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.
- ability to challenge current processes, practices, and strategy and uncover alternative approaches, solutions, or methods.
Nice to have
- Bachelor's degree in Engineering, Science, or relevant discipline
- or Master's Degree preferred
- Proficiency with software applications such as MS Office, SmartSheet, Veeva a plus
Compensation
- $160,000 - $195,000 USD
Company info
- We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease.
- At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.
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