Quality and Regulatory Affairs Manager

il y a 4 semaines

Marseille, France Softcell therapeutics Temps plein

**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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