Senior Manager QA Operations
HybridLondon, England, United Kingdom
London, England, United KingdomHybridFull TimeSenior LevelLarge
Full TimeSenior LevelLarge
Job Summary
Provide quality oversight for clinical studies and programmes across multiple therapeutic areas, partnering with clinical and medical teams to ensure compliance with Good Clinical Practice, regulatory requirements, and Ipsen quality standards. Drive risk-based quality oversight, inspection readiness, and continuous improvement initiatives while supporting quality planning, investigations, CAPAs, and oversight of service providers and vendors. Contribute to regulatory GCP inspections and audits across the global clinical development portfolio. Master's degree or equivalent scientific qualification required.
Required Qualifications
- 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
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