Senior Clinical Quality Manager - Expert

Nonstop-pharma is currently looking for a Clinical Quality Manager on behalf of a growing organisation which provides a combination of drug development expertise and clinical trial management. With a Europe-wide representation, they create and execute drug and medical device development programs.

Reporting to the Head of Quality assurance, your mission will be to act as a point of reference in clinical trials for clients and employees. You will therefore be considered as an expert and be responsible for developing, implementing and maintaining the QMS in accordance with clinical research regulations.

Your role will be divided between quality initiatives, audit activities, advice and expertise. As such, here is a non exhaustive list of the missions you will have to cover:

- Define quality procedures that are compliant with national and international standards and legislation
- Establish a clearly defined quality management system
- Ensure procedures are properly understood, carried out and evaluated by working closely together with the Training Department
- Investigate and report on deviations. Ensure effective root cause analysis is performed and adequate CAPA plans are defined and implemented.
- Provide expertise, guidance and support to all employees on GCP, Controlled Documents (CDs), quality and regulatory aspects
- Identify relevant quality-related training needs and support training (focusing on GCP, regulatory and CDs)
- Plan and conduct programmed and contracted audits according to applicable procedures and/or client expectations.

Your Profile
- Minimum 5 years' international experience in a quality assurance role for clinical trials
- Minimum of 2 years' auditing experience in GCP
- Fluent in French and English

If you are interested in this positon, please contact Chloé Khatcherian on 0033 1 76 75 33 40 or send your CV in Word format to c.khatcherian@nonstop-pharma.com