Senior Manager QA Operations

Overview

As Senior Manager, QA Operations you will provide quality oversight across Ipsen’s clinical studies, partnering with R&D and cross-functional teams to ensure GCP-compliant activities. You will lead risk-based quality oversight, inspection readiness, and continuous improvement within the clinical development portfolio. The role acts as a trusted quality partner to study teams, guiding QA decisions and regulatory readiness. This is a chance to drive quality excellence in a global, matrix organisation and support innovations in oncology, rare disease, and neuroscience.

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

Key requirements

• Significant Clinical Quality Assurance experience in pharma/biotech
• Direct experience supporting GCP-regulated clinical studies and development programmes
• Strong knowledge of GCP and quality oversight principles
• Experience in quality risk management, GCP inspections (MHRA, EMA, FDA), audit planning, investigations, and CAPAs
• Ability to collaborate and influence within a global matrix organisation
• Master’s degree or equivalent scientific qualification
• Fluent English

• collaboration
• influence within a global matrix
• problem-solving
• GCP
• quality risk management
• CAPA investigations

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