Director, Clinical Quality Assurance
2 weeks ago
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.
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@ and apply to this job posting.
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