Operational Quality Manager M/F
Machine translation — original language: French.Show original
As an Operational Quality Manager M/F, you are responsible for the compliance of internal and external control files, and the compliance of products before their release.
In this capacity, your missions are as follows:
- Manage the activity of the validation laboratory and support the development of your team's skills (20 people),
- Coordinate all internal and external control activities to guarantee product compliance and the availability of results necessary for their release,
- Supervise the control and release of raw materials, semi-finished products, and elements necessary for manufacturing,
- Write and update control and validation procedures and instructions,
- Guarantee the robustness of the laboratory's documentation system (procedures, instructions, control files) and ensure its application,
- Support teams in the application of quality requirements and participate in the continuous improvement of laboratory practices,
- Act as the QC referent during internal audits, client audits, regulatory inspections, and exchanges with external stakeholders.
Location: Villeneuve-d'Ascq
The sought profile:
- With higher education (Master's degree in biology or equivalent professional experience), you have at least 3 years of experience in a similar position and in a regulated environment (medical device, pharmaceutical, biotechnology).
- You have already managed a team, have solid knowledge of MD requirements, ISO 13485, and laboratory practices.
- You possess real managerial skills and demonstrate leadership and an entrepreneurial spirit.
Your ability to analyze, synthesize, and make decisions will allow you to successfully carry out your missions.
- You speak English
Contract: CDI