Executive Director, GCP Clinical Quality Assurance
3 weeks ago
Executive Director, GCP Clinical Quality Assurance
About the Company
Innovative biopharmaceutical company
Industry
Pharmaceuticals
Type
Privately Held
Founded
2018
Employees
11-50
Categories
Pharmaceuticals
Biotechnology
Health Care
Medical Care
Academic Research
Clinical Care
Cardiology
Collaboration
Entrepreneurial
Scientific
Manufacturing
Medicine
Chemical Products
About the Role
The Senior Director of GCP Clinical Quality Assurance at the company is a key leadership role with a focus on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The successful candidate will be responsible for ensuring that quality and compliance are integral to both long-term strategies and daily operations. This includes establishing and maintaining GCP QA programs, policies, and procedures, as well as driving continuous improvement initiatives across the organization. The role involves close collaboration with various internal and external stakeholders, such as clinical operations, clinical development, CMC, medical affairs, regulatory affairs, CROs, CDMOs, clinical trial sites, and laboratories. The Senior Director will also be accountable for inspection readiness, conducting audits, and managing quality issues, with a potential for future leadership responsibilities.Applicants for this position should have a Bachelor's degree in a scientific discipline and at least 12 years of relevant biotechnology experience, including a minimum of 3 years in a senior quality leadership role and 8 years in GCP quality assurance. The role requires a solid track record of compliance, successful audits, and experience in developing and maintaining QA systems. A deep understanding of the drug development process, global regulations, and GCP authorities is essential, as is the ability to work independently in a fast-paced environment. The ideal candidate will have a reputation for strong analytical thinking, a proven track record of driving major programs, and excellent communication skills for effectively engaging with a diverse workplace across all levels of the organization.
Hiring Manager Title
Vice President of Quality
Travel Percent
Less than 10%
Functions
General Management
Non-Profit Management
Strategy
Operations
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