Senior Manager QA Operations

Ipsen Group; Greater London; On-site; GBP 90,000 - 130,000; Full time

Job summary

Ipsen Biopharm Ltd in London is seeking a Senior Manager, QA Operations to provide quality oversight across Ipsen's clinical studies and programmes. You will partner with R&D, Global Medical Affairs and cross-functional study teams to ensure GCP compliance and Ipsen quality standards.

The role drives risk-based quality oversight, inspection readiness, continuous improvement and quality excellence across the clinical development portfolio. A Master's degree and strong English are required.

Qualifications

• Significant Clinical Quality Assurance experience in pharma/biotech.
• Direct experience with GCP-regulated studies and development programmes.
• Solid knowledge of GCP, regulatory requirements and Ipsen quality standards.
• Experience with quality risk management, inspections (MHRA/EMA/FDA), audits and CAPAs.

Responsibilities

• Provide quality oversight for clinical studies and programmes across therapeutic areas.
• Partner with clinical and medical teams to ensure strict GCP compliance.
• Offer QA guidance to cross-functional study teams and support quality planning.
• Lead investigations, CAPAs and quality improvement initiatives.
• Contribute to inspection readiness and regulatory GCP inspections.

Skills

GCP Knowledge

Quality Oversight

Regulatory Inspections

QA Experience

Risk Management

Cross-functional Collaboration

Education

Master's Degree

Job description

## Senior Manager QA OperationsApplylocations: London (UK)time type: Full timeposted on: Posted Todayjob requisition id: R-21979**Title:**Senior Manager QA Operations**Company:**Ipsen Biopharm Ltd**About Ipsen:**Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!For more information, visit us at **https://www.ipsen.com/**and follow our latest news on **LinkedIn** and **Instagram**.**Job Description:****Senior Manager, QA Operations****Clinical & Medical QA | Global Quality****Location: Paddington, London, UK****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.**Why Ipsen?**At Ipsen, you'll help ensure the highest standards of quality, compliance, and patient focus across our global clinical research activities while working alongside talented colleagues dedicated to bringing innovative therapies to patients.**Ready to Make an Impact?**If you're a Clinical QA professional with strong GCP expertise and hands-on experience supporting clinical studies, we'd love to hear from you.Apply today and help shape the future of innovative medicines at Ipsen.#LI-HYBRIDWe are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.