Executive Director GCP Quality Assurance

Meet Life Sciences; South San Francisco (CA); Hybrid; USD 130,000 - 190,000; Full time

Benefits offered by this job

Relocation Assistance

Flexible Work Schedule

Professional Development Opportunities

Job summary

An established industry player is seeking an Executive Director of Clinical Quality Assurance to lead their GCP QA initiatives. This pivotal role involves overseeing clinical programs, ensuring adherence to regulatory standards, and driving quality strategies across teams. The ideal candidate will possess extensive experience in GCP/GVP QA, strong leadership skills, and a deep understanding of health authority regulations. Join this forward-thinking organization to make a significant impact on the quality and compliance of clinical programs while enjoying a collaborative environment and the opportunity for professional growth.

Qualifications

• 12+ years of experience in GCP/GVP QA with a strong educational background.
• In-depth knowledge of FDA, ICH, and global health authority regulations.

Responsibilities

• Oversee quality of clinical programs ensuring risk management and compliance.
• Lead audit planning and execution, ensuring readiness for inspections.

Skills

GCP Quality Assurance

Risk Management

Regulatory Compliance

Leadership

Decision Making

Education

Bachelor’s or advanced degree in Biology

Bachelor’s or advanced degree in Chemistry

Related field experience

Job description

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.

Seniority level

• Director

Employment type

• Contract

Job function

• Quality Assurance and Research

Industries

• Staffing and Recruiting, Pharmaceutical Manufacturing, and Biotechnology Research