|Job title :||Manager of quality assurance operations|
|Location :||Marseille, Provence-Alpes-Côte d'Azur Region|
|Job type :||Permanent|
|Salary :||£50000.00 - £55000.00 per annum|
|Contact name :||Yannick Baroue|
|Contact email :||firstname.lastname@example.org|
This function pilots the quality assurance among the CCM plants as well as CMOs, ensures support, analyzes data to identify quality improvement actions, pilot harmonization subjects and best practices spread. Build the network needed among the sites.
Main Responsibilities & Tasks:
Pilot quality operation's team, manage capacity and priorities. Provide visibility of future resource needs
Developp skills, structure the team.
Is in charge of the team members' recruitment
Create a network towards the internal site's quality teams to create synergies, to share best practices, to build harmonization.
Is in charge of the quality management of CMOs as such:
In collaboration with PSNL team, participate into CMOs selection to make sure they meet the OPS unit specific needs
Ensure that quality KPIs are in place with the CMOs and lead the KPIs reviews and related action plans follow-up
Interact with CMOs to harmonize practices as much as possible versus internal sites
Be the partner of all the Sites (Internal & external Quality managers).
Support the Sartorius plants about critical investigation/ troubleshooting.
Drive the consistency & compliance between the sites, be a facilitator about any QA operations topics
Identify the risks and participate to manage them.
Analyze data to put in evidence the trends, the risks, the improvements done and to be done.
Master's degree in Science, Engineering or biotechnology
10+ years of experience in quality assurance with a successful experience as a manager - industries targeted biotech, pharma, API / excipients manufacturing.
Strong knowledge of GMP, Medical device & industry standards ( 21 CFRs/ ISO13485/ ICH Qs,…)
You already drove a Quality assurance team.
You are pragmatic and give sense to your choices. You quickly create good human relationships. You are able to constantly adapt yourself and to shape the future.
You already drove (or be part of) a quality management system in pharmaceutical industry and/or in an ISO 13485 environment.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.