Manager, QA operations

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

## Manager, QA operationsApply: Paris: London: Full time: Posted Today: R-22879**Title:**Manager, QA operations**Company:**Ipsen Innovation (SAS)**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:****About the Role**Join our Global Quality organisation as a **Manager, QA Operations**, supporting Clinical & Medical Quality Assurance. In this role, you’ll work closely with R&D and Global Medical Affairs teams to help ensure clinical studies and programmes are conducted in line with Good Clinical Practice, regulatory requirements and Ipsen quality standards.You’ll provide hands-on Quality Assurance expertise and guidance to cross-functional study teams, supporting quality oversight throughout the clinical lifecycle.This is a great opportunity for someone with established pharmaceutical Quality experience who is ready to broaden their experience across clinical studies, quality systems and compliance activities in a global environment. **Key Responsibilities*** Provide quality oversight for assigned clinical studies and programmes, ensuring alignment with **GCP, regulatory requirements and internal quality standards*** Partner with clinical and medical teams, providing practical **QA expertise and guidance*** Identify and manage quality risks, including **Quality Events, investigations, CAPAs and potential serious GCP breaches*** Support **inspection readiness, GCP inspections, quality assessments and audit activities*** Support risk-based quality oversight of **clinical service providers*** Contribute to the development and continuous improvement of the **Clinical & Medical Quality Management System** **What We’re Looking For*** **Established pharmaceutical industry experience, with a strong background in Quality supporting Medical Affairs and/or R&D*** Experience working with **interventional and/or non-interventional clinical studies*** Good working knowledge of **Good Clinical Practice (GCP)** and relevant clinical quality requirements* Strong collaboration, communication and problem-solving skills, with the ability to work effectively across functions in a global environment* A **master’s degree or higher** in a relevant scientific or life sciences discipline, with fluent English**Why Join Us?**Be part of a global Quality team where you can build your Clinical QA expertise, work with cross-functional teams and make a meaningful contribution to clinical quality and patient safety. **Ready to take the next step in your Clinical Quality career? Apply today and help us continue to strengthen quality across our clinical and medical activities.**#LI-Hybrid