Confidential
Executive Director, Research & Development Quality Assurance
Confidential, Bethesda, Maryland, us, 20811
Executive Director, Research & Development Quality Assurance
About the Company
Industry shaping developer of therapeutic medications
Industry Biotechnology
Type Public Company
Founded 2010
Employees 1001-5000
Categories
Biotechnology Genetics Health Care Medical Pharmaceutical
Specialties
biotechnology and mrna therapeutics
Business Classifications
Enterprise B2B
About the Role
The 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 Quality
Travel Percent Less than 10%
Functions
Engineering Non-Profit Management
Industry shaping developer of therapeutic medications
Industry Biotechnology
Type Public Company
Founded 2010
Employees 1001-5000
Categories
Biotechnology Genetics Health Care Medical Pharmaceutical
Specialties
biotechnology and mrna therapeutics
Business Classifications
Enterprise B2B
About the Role
The 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 Quality
Travel Percent Less than 10%
Functions
Engineering Non-Profit Management