Head of Quality Management

We are looking for the Head of Quality Management (F/M) for Polyplus, based in Illkirch (67). In this role, you will work with a team of around fifteen people and you will be responsible for defining and carrying out the Quality Assurance and Quality Control on product group/operational unit level, in respect with Sartorius standards, regulations and norms in place within the scope of activity.

The Head of Quality Management is accountable for ensuring the all-time readiness of plant for various GMP compliance audits, being the single point contact on all Quality matters.

**Polyplus (now part of Sartorius) is a leading provider of upstream solutions for the production of innovative drug therapies such as cell and gene therapies, from research to commercial scale.**
**Our mission is to develop innovative solutions that enable scientists to develop revolutionary nucleic acid-based therapies to improve human health.**

**Grow with us - Your Responsibilities**

**_Quality Assurance and regulatory affairs Oversee:_**
- Ensuring to** develop, implement, manage, audit and maintain **GMP and ISO quality systems**.
- Ensuring to perform all vendor qualification and compliance audits.
- Ensuring to develop, manage and maintain a **GMP compliant document control system**.
- Ensuring all non-conformances (deviations, errors etc.) are treated properly and in conformity with the quality system

**_ Quality Control and analytical development oversee:_**
- Ensure the management of all validation activities, including validation strategy and approval of protocols and reports.
- Ensure to Develop, communicate & adhere to best Testing practices to ensure that no non-conforming batch leaves Company premise
- Ensure qualification & maintenance of equipment's, department & premises.

**What will convince us**
- Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
- Quality professional with **15+ years **of hands-on experience with increasing responsibility in a QA function in an international environment (**French and English mandatory**)
- Prior responsibility for Quality Control would be a plus.
- Hands on experience **implementing quality systems in a GMP environment**, and **direct experience with FDA** and other health authority inspections. Extensiveknowledge of various GMP compliances regulations and industry practices.
- Ability to critically evaluate and troubleshoot complex problems is essential.
- Strong hands-on** leadership and management skills** with a - can do
- attitude.
- Ability to effectively participate on multi-disciplinary teams.
- Ability to absorb, digest and relate detailed scientific, quality, and regulatory information.
- Well-organized and detailed oriented professional, with strong verbal and written communication skills.
- Good understanding of the pharmaceutical market, including the unlicensed medicines sector.
- Wide knowledge of products and processes used in the manufacture of unlicensed medicines.
- Highly customer focused. Excellent project management skills.
- Adept at Conflict Management & resolution

**Ready to join Sartorius?**:

About Sartorius

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.

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Equal Opportunity Employer

At Sartorius, we believe that bringing together diverse perspectives is critical for our mission of simplifying progress in life sciences and bioprocessing so that new therapeutics can reach patients worldwide.

We therefore actively recruit and hire diverse talent from a mix of cultures, genders, age groups, physical and mental abilities, educational backgrounds, career paths and more, and do not tolerate any discrimination against applicants or employees.

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