Project 55201 – Quality transition Manager



Contract Type

Candidate (Freelancer)

Company Type


Company Size

Big > 5000

Requested Expertise

Quality / Production / Logistics / Start-Up and Innovation

Profile Required

Hard Skills :
Vaccines processes (biological processes)
Inspection (ANSES)
Qualification & Validation

Soft skills:
Decision making
Transversal work

Experience :
> 10 years

Project Description

As part of a project to create a new antigen production unit.
The systems addressed are, among others, the following systems:
• Aseptic biological processes (process vessels, piping, filters, HFL, Isolator, Autoclave, centrifugation, cells culture, viral culture, temperature controlled enclosures, …)
• computerized systems
• Clean room
• Aerial Decontamination system
• Pharmaceutical processes utilities (clean steam, water for preparation injectable, compressed air, etc.) and technical utilities

This job position of quality assurance is to ensure the role and responsibilities
associated with the mission of a transition manager

This mission includes, but is not limited to:
• Lead Quality Assurance activities related to project activities to maintain the
compliance with the applicable GMP and Group rules.
• Its action is part of a process of continuous improvement and respect for the values of group and its requirements in terms of HSE, quality, costs and deadlines.
• Be responsible for daily performance and results, preventive measures and
corrective implemented.
• To be the key user in the preparation and deployment of the sector’s Quality strategy. The candidate will have to deploy the priority approaches and programs for his sector, and promote operational excellence

As Quality transition manager, the candidate will be in charge of the following quality activities:
• Provide quality expertise to the various project stakeholders and validate decision-making to ensure sustainable Quality compliance at the new production site.
• Tracking of deviations associated with these steps.
• Coach and lead the Quality Assurance team (4 people).
• Define organizational models for Quality activities.
• Recruit and manage the user QA team.
• Participate in the selection and quality management of raw material suppliers and subcontractors.
• Participate in the IT application deployment plan to ensure the new building
has, in time, the necessary systems to start processes.
• Develop and monitor the implementation of the new building quality assurance system by
operational documentation terms, staff training, need for supplier audits
and subcontractors, preparation for inspections.
• Ensure the quality compliance of the new site with the various regulations and internal procedures
• Ensure the integration in the global organization
• Enable project advocacy to authorities.

Therapeutic Area




Hard Skills

Antigen,Manufacturing Execution Systems (MES),Project Management Office,Fluency in English,Experience > 10 years

Soft Skills

Agility,Autonomous / self-management,Collaboration,Decision making

Seniority Level

Experience > 10 years

Starting Date


Project Duration

6 Months until 2 years

FTE / nb of days per week


Project Location

LYON remote (1 or 2 days per week), France

Remote Flexibility


Travel Expected


Approximative Budget

Any other information of interest

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