Site Quality Head

hace 2 semanas

Tres Cantos, España Merck KGaA Darmstadt Germany A tiempo completo

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**: An exciting opportunity to lead the Quality Unit at the biotechnology site of Tres Cantos - Madrid (Quality Assurance, Quality Control, and local Regulatory Compliance) to ensure that materials and products manufactured, controlled, stored, and shipped by production meet the appropriate Quality Standards and are in compliance with current Good Manufacturing Practices (cGMPs), Healthcare Quality Systems and Regulatory files.

You ensure the implementation and monitoring of the site Quality System and maintain up-to-date registration and operational documents including Procedures, Specifications, and Site Master Files. You enable the release of the drug substances, following GMP normative, quality standards, and corporate policies and procedures. You provide a Quality Unit service to meet requirements and the company's business plans. You are the site contact with Health Authorities for quality-related activities. You enjoy leading a team of qualified professionals and developing the function to a bright future. As a member of the Tres-Cantos Site LT as well as the Biotechnology Quality LT you will contribute to living our High Impact Culture.

**Who you are**:

- You have a Master's Degree in Science (Pharmacy, Chemical, Biology, or equivalent)
- You have a minimum of 10 years of experience in the Pharmaceutical/Biotech industry in quality or manufacturing roles
- You have experience in a leadership position, developing a team in a collaborative, fast-paced environment, and the ability to communicate with impact
- You have in-depth experience in QA and are used to contributing and/or leading HA inspections
- You have expertise in QC and the development/optimization of analytical methods for biotechnology products.
- You are fluent in English (mandatory) and highly recommended in Spanish

**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

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