What are the responsibilities and job description for the Sr Director Clinical Quality Assurance position at Meet Life Sciences?
Senior Director, Clinical Quality Assurance Job Summary
This role is responsible for ensuring the quality of clinical programs throughout their lifecycle. The Senior Director will drive the quality strategy, provide operational guidance to development teams, and lead the internal GCP QA team.
Key Responsibilities
- GCP QA Program Development: Develop and maintain GCP QA programs to ensure compliance with health authority regulations and guidelines.
- Audit Planning and Execution: Lead audit planning and execution, provide quality oversight for clinical documents, and ensure inspection readiness.
- Clinical Service Provider Selection: Support clinical service provider selection, manage KPIs, and guide cross-functional teams on quality matters.
Qualifications
- Education: Bachelor's or advanced degree in Biology, Chemistry, or related field.
- Experience: 12 years of GCP/GVP QA experience with strong knowledge of FDA, ICH, and global health authority regulations, particularly in small molecule products.
- Leadership Skills: Proven leadership skills, ability to make sound decisions in complex environments, and prior management experience.
Additional Requirements
- Travel: Some travel required for inspections, audits, and meetings.
