What are the responsibilities and job description for the Manager/Director of Quality Assurance - CRO position at Kingsley-Rose Executive Search?
Job Title : Manager / Director of Quality Assurance
Position Summary
Our client seeks an experienced and dynamic Manager / Director of Quality Assurance (QA) to join their team in the East Bay region of the San Francisco Bay Area. Reporting directly to the Chief Scientific Officer (CSO), this role is pivotal in establishing and maintaining robust quality systems for nonclinical laboratory studies compliant with Good Laboratory Practice (GLP) and clinical study testing activities aligned with Good Clinical Laboratory Practice (GCLP). The Director of QA will ensure facilities, equipment, personnel, and processes adhere to regulatory standards, supporting our organization’s commitment to excellence and compliance.
Key Responsibilities
Inspection Readiness & Audits :
- Host client and regulatory inspections, including preparing comprehensive responses to findings.
- Plan, conduct, and report internal facility inspections and external vendor audits to assess compliance with regulations and industry best practices.
Regulatory Compliance & Support :
Documentation & Reporting :
Team Leadership & Development :
Training & Communication :
Qualifications & Educational Requirements
Education :
Experience :
Skills :
Why Join Us?
This is an opportunity to play a leadership role in a company that values quality, innovation, and collaboration. You’ll work in a fast-paced, science-driven environment, shaping regulatory practices that impact critical research and development efforts globally.