Quality and Regulatory Affairs Manager
il y a 1 jour
**About Us**
Cellura is a company specializing in providing cellular bioreactors for the academic world, biotechs, and pharmaceutical companies.
After validating the R&D phase, Cellura is now in the stage of making products available on the market, offering an innovative and revolutionary solution for the industrial-scale production of sensitive cells, such as stem cells.
**Overview**
We are looking for a **Quality and Regulatory Affairs Manager (M/F)** to strengthen our team and establish the QMS (Quality Management System). As part of the creation of this position and department, we are seeking a Quality and Regulatory Affairs Director to establish and manage the entire QMS.
**Responsibilities**
- Establish and manage the QMS.
- Ensure products obtain ISO certifications and regulatory validations.
- Collaborate with quality consulting firms in France and abroad.
- Conduct ongoing regulatory monitoring to ensure product compliance.
- Work closely with internal and external teams to ensure adherence to quality standards.
**Requirements**:
- A degree in pharmacy or a PhD in biotechnology is a plus.
- Over 5 years of experience in a quality management role within the biotechnology sector.
- Proficiency in written and spoken English (required).
- Autonomy, entrepreneurial spirit, and strong command of digital and QMS tools.
- In-depth knowledge of regulations and quality standards in the biotechnology sector.
**Job Types**: Full-time, Permanent
Status: Cadre
Pay: 42,000.00€ - 60,000.00€ per year
**Education**:
- Master's (required)
**Experience**:
- Quality and Regulatory Affairs Manager: 5 years (required)
Work Location: In person
Expected Start Date: 21/04/2025
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