About this role
Title:
STAGE CM QUALITY SYSTEMCompany:
Ipsen Pharma (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:
POSITION
Job Title: Clinical and Medical Quality System Trainee
Division / Function: Clinical & Medical QA – Global Quality
Location: Paris, France
WHAT - Summary & Purpose of the Position
Ensuring a compliant state of the Quality Management System applicable to clinical studies managed by IPSEN R&D
and Medical Affairs (compliance to GCP, GVP, GPP, applicable regulation and standards).
WHAT - Main Responsibilities & Technical Competencies
Quality Systems:
o Contribute to the maintenance of the Quality Management System governing clinical studies.
o Monitor quality performance of C&M QA: data collection, targets definition, best practices promotion,
improvement initiatives, and appropriate reporting.
o Ensure proper management of eQMS records (Quality Events, system/process audits, Inspection readiness
and inspections, Change Control, process risk)
Training
o Guide system users to ensure they are trained when required (e.g. when a specific training task is required)
o Liaise with process owners and trainers to ensure appropriate training material is generated and made
available for clinical research activities
Quality Objectives and culture
o Conduct periodic reviews of the quality system in scope
o Monitor QMS KPIs
o Provide periodic quality updates to the Lead CM Quality System
o Encourage best practices, especially from a continuous improvement perspective.
Other
o Respect and enforce current EHS regulations and procedures.
o Promote an EHS dynamic within the teams for the proper functioning of the EHS management system
o Ensure that mandatory EHS training is carried out by its employee
HOW - Knowledge & Experience
Education / Certifications (essential):
· Bachelor’s degree or higher in relevant scientific life science or other relevant scientific qualifications
Education / Certifications (preferred):
· Not Applicable
Language(s) (essential):
· Fluent English and French
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-mêmeAbout Ipsen
Global specialty-driven biopharmaceutical company focused on oncology, rare disease, and neuroscience. Headquartered in Paris, France.
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