Global QA Operations Manager — Clinical Quality & GCP

Ipsen; Paris; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Ipsen Innovation (SAS) in Paris is seeking a Manager, QA Operations to join our Global Quality organization. You will provide hands-on QA expertise to cross-functional study teams across clinical lifecycle, ensuring GCP and Ipsen quality standards are met.

The role focuses on quality oversight of clinical studies, risk-based approach, and readiness for inspections, enabling patient safety and regulatory compliance on global programmes.

Qualifications

• Established pharmaceutical industry experience with QA supporting Medical Affairs and/or R&D.
• Experience with interventional and/or non-interventional clinical studies.
• Strong knowledge of Good Clinical Practice (GCP).
• Fluent English.

Responsibilities

• Provide quality oversight for assigned clinical studies and programmes, ensuring alignment with GCP and regulatory requirements.
• Partner with clinical and medical teams, providing QA expertise and guidance.
• Identify and manage quality risks, including quality events, investigations, CAPAs and potential serious GCP breaches.
• Support inspection readiness, GCP inspections and audit activities.
• Support risk-based quality oversight of clinical service providers.
• Contribute to development and continuous improvement of the Clinical & Medical Quality Management System.

Skills

Quality assurance

GCP knowledge

Regulatory knowledge

Cross-functional collaboration

QA inspections

Education

Master's degree in life sciences

Job description

Ipsen Innovation (SAS) in Paris is seeking a Manager, QA Operations to join our Global Quality organization. You will provide hands-on QA expertise to cross-functional study teams across clinical lifecycle, ensuring GCP and Ipsen quality standards are met.

The role focuses on quality oversight of clinical studies, risk-based approach, and readiness for inspections, enabling patient safety and regulatory compliance on global programmes.