Quality system management leader

Job title : Quality system management leader
Location : Marseille, Provence-Alpes-Côte d'Azur Region
Job type : Permanent
Salary : £50000.00 - £55000.00 per annum
Contact name : Yannick Baroue
Contact email : yannick.baroue@secpharma.com

This function pilots the quality management system among CCM sites, creates and leads the adequate network about all QMS subjects (documentation, data integrity, internal audits, risk management, KPI, …).
This function reports to the CCM Quality assurance manager.


Main Responsibilities & Tasks:

Drive the consistency and the compliance of the Quality System by implementing: adequate documentation, meaningful KPI, internal audit plan, cross audits between sites, between operational units efficient CAPA management.
Be the partner and the relay of sites and global QMS functions (named BPS)
Use the network to create synergies, to share best practices, to share audits observations, to improve and continue to build harmonization.
Drive creation, review and implementation of common documents
Support internal, external audits related to his/her scope of expertise where appropriate
Support the development of the risk management
Improve training system and efficiency
Assure Data Integrity for CCM sites

Profil required:

Master degree in Engineering or biotechnology
Min. 7 years' experience in production or in engineering center - industries targeted biotech, pharma, API/Excipients manufacturing, culture media.
Strong GMP, Medical device & industry standards knowledge ( 21 CFRs/ ISO13485/ ICH Qs,…)


You already implemented or participated to the implementation of a QMS and drove (or be part of) a quality management system in pharmaceutical industry and/or in an ISO 13485 environment.

You are pragmatic and give sense to your choices. You quickly create good human relationships. You are able to constantly adapt yourself, to work in a matrixial environment and to shape the future.

You want to be part of a dynamic company where quality is a key objective. You want to work for customers manufacturing medicines. You want to be part of a multi-cultural team over the world and be ready to travel in US, Europe and Asia.