We assist our clients through non-clinical and clinical studies to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

Quality Assistance is always focusing on meeting customer expectations and quality standards requirements to ensure the scientific data reliability. In order to coordinate the management of Scientific Data through all operational processes, we are looking for a Scientific Data Integrity and Analysis Manager

YOUR MISSION

You will lead a team and report to the Scientific Operations Director
With team members, you will be involved in Scientific Data Integrity and Analysis projects management. Via those projects, in compliance with applicable regulatory standards and ALCOA+ principles, you will insure the “scientific meaning / reliability” of any data collected in the laboratories of Quality Assistance.

In this role, you will be accountable for:

• Ensure the quality and the completeness of the scientific data
• Develop and maintain the documentation of the processes for each system (lab equipment and/or related software)
• Take part to the purchase of the new systems
• In cooperation with the IT department, define and maintain the appropriate SDMS required for the following actions on the scientific data :
o Collect and transfer the data generated by different lab equipment
o Aggregate data generated in different formats
o Index data in order to allow an efficient search
o Process the data: edit report, trends analysis, statistical analysis, search,etc
o Manage de life cycle of the data including their archiving and destruction in agreement with the DIP
• Assist the users in their search and treatment of the data
• Take part to customer and regulatory audits
• Keep a regulatory watch related to the role.

PROFILE

Master’s degree in Science

Required:

- Working experience in the management of scientific Databases
- Working experience in a GMP environment
- Good knowledge of lab systems: equipment and software
- Knowledge and understanding of the relevant regulations
- Good business understanding, results oriented and problem solver
- Good organizational, reporting and communication skills
- Fluent in French - English level B1 (writing and listening).
A first experience in team management is a plus.

ABOUT QUALITY ASSISTANCE :

Quality Assistance is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.

We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

The company holds a unique position on the market with all its laboratories on one site, 200 highly qualified professionals and over 35 years’ expertise at the forefront of analytical sciences. The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

WHY JOIN QUALITY ASSISTANCE

• We are a true career partner.
• We accelerate people’s access to new medicines.
• We offer an inspiring work-life balance in a human scale environment.
• We care about mutual respect, assistance and communication.
• We listen to your needs and your suggestions.
• We offer a market-competitive remuneration package.

HOW CAN YOU APPLY ?

Send your application (reference JOB 218) now, for the attention of Bernard Adant, Talent Manager, to [email protected]

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