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Full-time
bachelor degree
Posted 19d ago
~40 hrs/week
Responsibilities
Lead the qualification and quality oversight of service providers supporting clinical studies to ensure compliance and continuous improvement. Partner with cross-functional teams in R&D and Medical Affairs to support inspection readiness and maintain strong quality systems.
Requirements
Requires a scientific degree and fluency in English with strong experience in pharmaceutical quality within R&D or Medical Affairs. Candidates must have solid knowledge of Good Clinical Practice and experience overseeing external service providers in regulated settings.
Full job description
Title:
Senior Manager, Lead QA Operations Service Provider
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!
Are you a quality expert with experience in clinical development and service provider oversight?
At Ipsen, we’re looking for a strategic QA expert to help shape quality excellence across our global clinical and medical operations. The Senior Manager, Lead QA Operations Service Provider , will lead quality oversight of service providers supporting clinical studies, drive compliance and continuous improvement, and partner closely with teams across R&D, Global Medical Affairs, and Procurement.
This is a highly collaborative role with broad visibility across key quality and business stakeholders.
What you’ll do
Lead the qualification, and oversight of service providers supporting clinical studies
Ensure quality agreements, compliance activities, and risk-based quality oversight processes are in place and effective
Monitor service provider quality performance, drive continuous improvement, and escalate quality issues where needed
Partner closely with cross-functional stakeholders to provide QA expertise and support inspection and inspection/audit readiness
Contribute to strong quality systems, team leadership, and a culture of excellence
What you’ll bring
Strong experience in pharmaceutical quality within R&D and/or Medical Affairs
Solid knowledge of Good Clinical Practice and clinical study environments
Experience overseeing external service providers in a regulated setting
Strong analytical skills and the ability to assess risk, investigate issues, and support effective CAPAs
A scientific degree
Fluent English
Join Ipsen and bring your quality expertise to a high-impact role shaping excellence across global clinical and medical operations.
#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
We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.
Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in 88 countries.
For more information, visit ipsen.com.
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Offices: 70, Rue Balard, Paris, Île-de-France 75015, FR · 9 Ash Road North, Wrexham, Wales LL13 9UF, GB · Algeria, DZ · 190 Bath Road, Slough, England SL1 3XE, GB · 1 Main St, Cambridge, Massachusetts 02142, US
PharmaceuticalsSpecialty care: oncologyneuroscienceendocrinologyResearch: peptidestoxinsand Primary CareHealth CareBiotechnologyProduct Research
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