GCP Quality Assurance Director
Behavioral Health Market Context
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Qualifications
- •At least 10 years of experience in GCP quality assurance, including audit planning and execution
- •Experience with ICH GCP, FDA regulations, and ideally EU / UK clinical trial regulations
- •Proven track record of preparing for regulatory inspections and audits
- •Experience developing and maintaining a GCP quality management system
- •Familiarity with eQMS platforms and the ability to manage and develop a small team
- •2 more items(s)
Responsibilities
- •Lead GCP quality assurance, including auditing, inspection readiness, and compliance with regulations
- •Oversee the Integrated Management System and ensure quality documentation is accurate and practical
- •Manage a small team and collaborate with clinical operations leadership to embed quality across the organization
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