Strategic Clinical Quality & Compliance Leader

Ipsen Biopharmaceuticals Inc.; Greater London; Vor Ort; GBP 70.000 - 110.000; Vollzeit

Zusammenfassung

Ipsen Biopharm Ltd is seeking a Clinical Quality and Compliance Lead to ensure ongoing compliance with Quality Standards, SOPs, and regulatory guidelines across Ipsen clinical trials. The role partners with Head Site Management and Monitoring and TA Leads to drive quality initiatives and CAPA programs.

The candidate will collaborate with Clinical Operations teams, build the cluster quality plan, and maintain inspection readiness across studies, while leading internal quality improvements and

Qualifikationen

• Experience in clinical QA and regulatory compliance.
• Strong communication and leadership abilities in cross-functional teams.
• Ability to identify gaps, implement remediation plans and monitor CAPAs.

Aufgaben

• Contribute to a long-term cluster quality plan ensuring high-quality trial delivery.
• Identify compliance risks and define remediation actions at study and site levels.
• Support investigations and CAPA management with structured problem-solving approaches.
• Assist in audit and inspection readiness and respond to data requests by SMEs.

Kenntnisse

Quality Assurance

Regulatory Compliance

CAPA

GxP

Tools

QMS

Jobbeschreibung

Ipsen Biopharm Ltd is seeking a Clinical Quality and Compliance Lead to ensure ongoing compliance with Quality Standards, SOPs, and regulatory guidelines across Ipsen clinical trials. The role partners with Head Site Management and Monitoring and TA Leads to drive quality initiatives and CAPA programs.

The candidate will collaborate with Clinical Operations teams, build the cluster quality plan, and maintain inspection readiness across studies, while leading internal quality improvements and