Actalent
GCP Quality Assurance Director
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Responsibilities
This role is responsible for overseeing the design, implementation, and ongoing enhancement of a risk-based GCP Quality Assurance function that supports the entire clinical development lifecycle.
Responsibilities:
- Define and execute the global GCP QA strategy aligned with organizational and clinical development objectives
- Ensure effectiveness of key quality systems (deviations, CAPA, change control, training, document management) in a GCP environment
- Design and lead a comprehensive, risk-based GCP audit program covering: Investigator sites, CROs and vendors, Internal systems, processes, and databases
- Act as the primary GCP QA advisor to R&D and external partners
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Requirements:
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- Minimum 10 years of experience in Clinical Quality Assurance or a related GxP quality role, with a strong understanding of quality management principles within clinical development.
- Demonstrated experience conducting and managing GCP audits, including investigator sites, vendors, CROs, and clinical systems, with a thorough understanding of ICH-GCP guidelines and regulatory requirements.
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