Senior Director, GMP Quality Operations

2 weeks ago


Waltham, Massachusetts, United States BioSpace, Inc. Full time
Job Title: Senior Director, GMP Quality Operations

At Dyne Therapeutics, we are seeking a highly experienced Senior Director to lead our GMP Quality Operations team. As a key member of our Quality department, you will be responsible for ensuring the quality of our external manufacturing operations globally and internal GMP operations for development and commercial programs.

Key Responsibilities:
  • Develop and manage contract development manufacturing organization (CDMO) Quality relationships
  • Build and maintain the GMP Quality Operations structure to support Dyne's business needs
  • Collaborate with internal business stakeholders and Quality functions to deliver quality outcomes
  • Oversight of department activities, budgeting, and personnel development
  • Ensure the quality of deliverables within the role's purview
Requirements:
  • Minimum of 10+ years of experience in a quality role with direct reports, preferably in GMP Quality Operations in a clinical late-stage and/or commercial biotechnology company
  • Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority
  • Excellent written and oral communication skills, including well-developed presentation skills
  • Strong collaboration and interpersonal skills to effectively interact with internal or external stakeholders at all levels in the organization

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking to join a dynamic team, please submit your application.



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