Senior Manager QA Operations

Senior Manager QA Operations

Ipsen Pharma

London, United Kingdom

About the Role

We're looking for an experienced Clinical Quality Assurance professional to join our Global Quality organisation. In this role, you'll partner with R&D, Global Medical Affairs, and cross-functional study teams to provide quality oversight and support across Ipsen's clinical studies and programmes.

Acting as a trusted quality partner, you'll help ensure clinical activities are conducted in compliance with Good Clinical Practice (GCP), applicable regulations, and Ipsen quality standards. You'll also drive risk-based quality oversight, inspection readiness, continuous improvement, and quality excellence across our clinical development portfolio.

Key Responsibilities

• Provide quality oversight for clinical studies and programmes across multiple therapeutic areas.
• Partner with clinical and medical teams to ensure compliance with GCP, regulatory requirements, and Ipsen quality standards.
• Provide QA expertise and guidance to cross-functional study teams.
• Support quality planning, risk management, investigations, CAPAs, and quality improvement initiatives.
• Contribute to inspection readiness, regulatory GCP inspections, audits, and quality assessments.
• Support oversight of service providers, vendors, and clinical partners.
• Promote continuous improvement across clinical and medical quality systems and processes.

What We're Looking For

• Significant Clinical Quality Assurance experience within the pharmaceutical or biotechnology industry.
• Direct experience supporting GCP-regulated clinical studies and clinical development programmes (interventional and non-interventional clinical studies).
• Strong knowledge of Good Clinical Practice (GCP) and quality oversight principles.
• Experience supporting quality risk management, GCP inspections (e.g., MHRA, EMA, FDA), audit planning, investigations, and CAPAs.
• Ability to collaborate and influence effectively within a global matrix organisation.
• Master's degree or equivalent scientific qualification.
• Fluent English.