What are the responsibilities and job description for the GCP QA Program Manager position at Meet Life Sciences?
About the Role:
The Senior Director of Clinical Quality Assurance (GCP) will play a critical role in ensuring the quality of clinical programs throughout their lifecycle including oversight risk assessment and compliance with regulatory standards. This role will drive the quality strategy provide operational guidance to development teams and lead the internal GCP QA team.
Job Responsibilities:
- Develop and maintain GCP QA programs ensuring compliance with health authority regulations and guidelines.
- Lead audit planning and execution providing quality oversight for clinical documents and ensure inspection readiness.
- Support clinical service provider selection manage KPIs and guide cross-functional teams on quality matters.
Requirements:
- Bachelor's or advanced degree in Biology Chemistry or related field with 12 years of GCP/GVP QA experience.
- Strong knowledge of FDA ICH and global health authority regulations with experience in small molecule products.
- Proven leadership skills ability to make sound decisions in complex environments and prior management experience.
About Meet Life Sciences:
Meet Life Sciences is a company that values quality and excellence in all aspects of our business. We are committed to delivering high-quality products and services to our customers.
