Dyne Therapeutics

Dyne Therapeutics

Associate Director, GMP QA Operations

Waltham, MA · Director

Sponsorship not specified$160k-$195kDetected 16 days ago
AccessibilityProject ManagementAuditingGMPFDA RegulatoryMedical DevicesAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingMentoringMicrosoft OfficeInternal AuditGxPRegulatory 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

  • Serves as QA lead for external manufacturing and testing teams, providing technical guidance and quality oversight
  • Represents QA Operations in interactions with CMOs and external partners
  • Leads or supports investigations into significant quality issues, driving root cause analysis and CAPA development, tracking, and effectiveness verification
  • Supports change management activities impacting manufacturing and testing
  • Supports regulatory submissions, including investigational new drug applications and related correspondence
  • Develops, implements, and maintains Quality Systems, procedures, policies, and metrics supporting GMP operations
  • Drives improvements to batch record review processes and ensures timely resolution of compliance issues
  • Manages CMO documentation and ensures accessibility of quality records
  • Develops and monitors Quality Operations metrics (KPIs) for Management Review
  • Participates in domestic and international audits of CMO sites and supports internal audit programs

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.
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This listing is sourced directly from Dyne Therapeutics's careers page and normalized into a canonical job model.