Executive Director, Site Quality Lead
Confidential
Executive Director, Site Quality Lead
About the Company
Innovative biotechnology company
Industry
Pharmaceuticals
Type
Public Company
Founded
2015
Employees
501-1000
Categories
- Pharmaceuticals
- Biotechnology
- Health Care
- Medical Conditions
- Clinical Care
- Biotech
- Academic Research
- Collaboration
- Manufacturing
- Medicine
- Chemical Products
Specialties
- biotechnology
- neurodegenerative disease
- neurodegeneration
- and pharmaceuticals
About the Role
The Company is seeking an Executive Director & Site Quality Lead to join their team. The successful candidate will be a key member of the site leadership team, with a primary focus on building and leading the QA and QC teams to ensure the site is in a state of readiness for commercial product launch. This role is pivotal in fostering a culture of innovation, continuous improvement, and adherence to core values. The Executive Director will be responsible for overseeing GMP/GLP quality operations, including quality control laboratories, batch record reviews, and environmental monitoring. They will also be accountable for the site's overall compliance and inspection readiness, serving as a strategic partner in developing and maintaining site culture and long-term strategy. Applicants for this role at the company should have a BS in a scientific discipline, with an MS and professional certification in quality, compliance, and/or regulatory preferred, and at least 15 years' GMP experience in the pharmaceutical industry. A strong background in in-house manufacturing, QC testing, and CMC development is essential, with experience in large molecule or commercialization being a plus. The ideal candidate will have a current and strong working knowledge of relevant regulatory guidelines and experience in inspection management and health authority interactions. The role requires the ability to travel domestically and internationally and a proven track record in leading and developing teams.
Hiring Manager Title
Vice President of Quality
Functions
- Operations
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