Senior Manager, GCP QA — Clinical Quality Leadership
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14 days+
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Job summary
A leading healthcare consultancy is seeking a Senior Manager for Quality Assurance to lead clinical compliance efforts. This position requires 10+ years of experience in the industry and 5+ years in Clinical Quality Assurance. Key responsibilities include overseeing quality risk assessments, conducting audits, and ensuring regulatory readiness for global studies. The ideal candidate has strong insight into GCP regulations, possesses excellent communication skills, and has experience with quality management systems. This hybrid role is based in the San Francisco Bay Area.
Qualifications
- 10+ years of industry experience or 7+ years with an advanced degree.
- 5+ years of direct experience in Clinical Quality Assurance.
- Experience in leading Phase 1-III GCP audits.
Responsibilities
- Serve as the CQA representative on Study Execution Teams.
- Plan and conduct audits for investigator sites and CRO.
- Support mock inspections for global health authorities.
Skills
Clinical Quality Assurance
Risk-based audit planning
Understanding of ICH-GCP
Collaboration and communication
Root Cause Analysis (RCA)
Education
Bachelor's degree in life sciences or related field
Advanced degree
Tools
Veeva Vault
Job description
A leading healthcare consultancy is seeking a Senior Manager for Quality Assurance to lead clinical compliance efforts. This position requires 10+ years of experience in the industry and 5+ years in Clinical Quality Assurance. Key responsibilities include overseeing quality risk assessments, conducting audits, and ensuring regulatory readiness for global studies. The ideal candidate has strong insight into GCP regulations, possesses excellent communication skills, and has experience with quality management systems. This hybrid role is based in the San Francisco Bay Area.
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