What are the responsibilities and job description for the Sr Director Clinical Quality Assurance position at Meet Life Sciences?
Job Title: Senior Director, Clinical Quality Assurance
Work Arrangement: 3 days onsite in South San Francisco per week
Benefits: Relocation Assistance provided
Job Overview: The Senior Director of Clinical Quality Assurance (GCP) oversees the quality of clinical programs throughout their lifecycle. This role drives the quality strategy, provides operational guidance to development teams, and leads the internal GCP QA team.
Main Responsibilities:
- Develop and maintain GCP QA programs to ensure compliance with health authority regulations and guidelines.
- Lead audit planning and execution, providing quality oversight for clinical documents, and ensuring inspection readiness.
- Support clinical service provider selection, manage KPIs, and guide cross-functional teams on quality matters.
Qualifications:
- Bachelor's or advanced degree in Biology, Chemistry, or a 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.
Additional Requirements:
- Some travel required for inspections, audits, and meetings.
