Job Description

Director, GCP QA Compliance

Our biotech partner is a well-established, commercially successful clinical stage biotech that is seeking a Director of Clinical Quality Assurance to lead the CQA function and build/manage a team. This role will oversee CQA strategy across policies, SOPs, deviations, change control, CAPAs, and vendor audits. This is a great opportunity for a Clinical QA leader to help progress a robust pipeline of therapeutics across oncology, neurology, endocrinology, and more areas. This position will be 3 days onsite in Redwood City, CA.

>>> We are open to candidates across the US who are intent on relocating to the Bay Area <<<

Responsibilities:

• Lead Clinical Quality Assurance as a manager to the CQA team supporting various therapeutic area programs in support of successful clinical studies
• Lead GCP audit strategy including audits of investigative sites, clinical vendors, internal department, TMF, and study documents
• Represent QA on clinical teams to provide compliance assessment and advice
• Manage clinical inspections by regulatory bodies across internal and external stakeholders/vendors
• Hold quality metric analysis for CQA across deviations, CAPAs and other events
• Use a risk-based approach to implement clinical program audit plans

Requirements:

• Bachelor’s or Master’s in a scientific field with progressive experience in biotech/pharma clinical quality for at least 12 years in industry
• Strong knowledge of GCP QA regulatory requirements and quality systems
• Experience developing and managing quality processes
• Risk management, root cause analysis, and inspection support experience
• Excellent communication, project management, and organizational skills
• Demonstrated managerial experience of CQA function in biotech/pharma

Contact:

To have a confidential discussion, please contact Amit at amit.uma@meetlifesciences.com and apply to this job posting.

Job Tags

Similar Jobs