About this opportunity
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
Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us*». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même
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