Executive Director GCP Quality Assurance

Job Title:
Executive Director, Clinical Quality Assurance

3 days onsite in South San Francisco per week

Relocation Assistance provided for non-local candidates

Job Overview:

The Executive Director of Clinical Quality Assurance (GCP) will oversee the quality of clinical programs throughout their entire lifecycle, ensuring risk management, regulatory compliance, and effective oversight. This position will be responsible for driving the quality strategy, offering operational support to development teams, and leading the internal GCP QA team.

Key Responsibilities:

• Develop and maintain GCP QA programs to ensure adherence to health authority regulations and guidelines.
• Lead audit planning and execution, provide quality oversight for clinical documentation, and ensure readiness for inspections.
• Assist with the selection of clinical service providers, manage key performance indicators (KPIs), and offer guidance to cross-functional teams on quality-related matters.

Qualifications:

• Bachelor’s or advanced degree in Biology, Chemistry, or a related field, with 12+ years of experience in GCP/GVP QA.
• In-depth knowledge of FDA, ICH, and global health authority regulations, with specific experience in small molecule products.
• Proven leadership skills, demonstrated ability to make informed decisions in complex settings, and prior management experience.

Additional Requirements:

• Some travel may be required for inspections, audits, and meetings.

• Director

• Contract

• Quality Assurance and Research

• Staffing and Recruiting, Pharmaceutical Manufacturing, and Biotechnology Research