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Executive Director, Research & Development Quality Assurance
Somerville, MAApril 1st, 2026
Executive Director, Research & Development Quality AssuranceAbout the CompanyIndustry shaping developer of therapeutic medicationsIndustry
BiotechnologyType
Public CompanyFounded
2010Employees
1001-5000CategoriesBiotechnology
Genetics
Health Care
Medical
PharmaceuticalSpecialtiesbiotechnology and mrna therapeuticsBusiness ClassificationsEnterprise
B2BAbout the RoleThe Company is seeking an Executive Director for Research and Development Quality Assurance. This critical leadership role is pivotal in shaping and driving the global R&D quality strategy across all GxP domains. The successful candidate will be responsible for setting the strategic direction, governance model, and operational excellence framework for quality within research and development. This includes serving as the most senior QA leader across GCP, GLP, GCLP, and GVP, and ensuring end-to-end regulatory compliance, scientific integrity, and patient safety. The role demands a seasoned quality executive with a strong background in the biopharmaceutical industry, particularly in the areas of GCP, GLP, GCLP, and GVP, and a proven track record of leading multifunctional quality organizations.Key responsibilities for the Executive Director include providing enterprise governance and oversight of GCP, GVP, GLP, and GCLP compliance, defining and executing a robust quality strategy, and acting as the primary quality business partner to R&D functional leaders. The role also involves embedding risk-based quality management principles, driving modernization of vendor oversight, and leading a high-performing QA team. The ideal candidate will have a Bachelor's degree in a life science or related field, with an advanced degree preferred, and at least 18 years of progressive quality experience in the biopharmaceutical industry. They should possess extensive knowledge of global regulatory requirements and a proven ability to collaborate and influence in a fast-paced, matrixed environment. Exceptional leadership, strategic thinking, and a strong commitment to a culture of continuous improvement and innovation are essential.Hiring Manager Title
Head of QualityTravel Percent
Less than 10%FunctionsEngineering
Non-Profit Management
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