Senior Manager GD GCP Auditing (UK)
Core
Lead risk-based quality auditing activities and strengthen GCP compliance for global development clinical studies.
Role type
Senior Manager, GCP Auditing
Builds
Quality assurance processes and compliance for global clinical development programs
Domain
Life Sciences / Clinical Research / Regulatory Compliance
Required skills
GCP audit leadership, FDA/EU/ICH regulatory knowledge, process/site/vendor/partner audit execution, regulatory inspection management, complex GxP issue resolution, senior stakeholder interfacing, project management
Preferred skills
Master's degree, advanced leadership in ambiguous environments
Technologies
GCP, FDA regulations, EU regulations, ICH guidance
Responsibilities
Lead end-to-end GCP audits across internal and external global activities; Schedule, conduct, report, and follow up on routine and directed audits; Develop and execute risk-based audit programs for assigned clinical studies; Identify compliance issues and drive process improvements and standardization; Represent Quality Assurance on complex compliance projects and initiatives; Interpret policies, standards, and regulations to address critical issues; Support regulatory inspections and inspection room activities
Seniority
Senior Manager, hands-on leadership
