Site Quality Head

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your role**

Your main responsibility is to manage the Quality of the Semoy production site in respect of Quality Systems in place for full compliance of products and services related to it in accordance with GMP and the requirements and regulations in force (Europe, USA, Japan). As Site Delegate Pharmacist f/m, you organize and supervise the pharmaceutical operations by delegation of the company Responsible Pharmacist.

You manage and respect the Quality Systems in accordance with the current GMP. You manage the Quality Assurance and Quality Control departments (team of 80 people) and ensure the establishment and monitoring of harmonized systems between different departments. You are the partner of the site with the authorities during inspection (Ansm, FDA, MHLW JP, Anvisa...) and external audits (EQQ, HCQ and Contract Givers when acting as a CMO). You implement on the site, the HCQ objectives in collaboration with the site Head and the Head of Europe Pharma Quality cluster. You oversee the management of the QC team and officials QA of the different areas of the site (sterile forms, forms dry, packaging) and the analysis and treatment of the customer complaints via quality assurance managers. You achieve a regulatory monitoring and guarantee the compliance of Drug Product manufactured at the site according to Marketing Authorization Dossier. You oversee the disposition process for the release or rejection of lots, and detect risks of non-compliance and triggers preventive actions.

This position is located in Semoy, France (45 - Orléans).

**Who you are**
- Minimum of 10 years' experience as a Quality Manager of a pharmaceutical &/or chemical production site
- Pharmacist (Pharmacien thésé) with experience as Responsible Pharmacist, Deputy Responsible Pharmacist or Site Delegate Pharmacist
- Proven ability and experience in managing multidisciplinary teams
- Strong experience in implementing processes and plans to achieve operational quality excellence on production sites
- Fluent in French and English mandatory

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress