STAGE CM QUALITY SYSTEMIPSEN

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