Site Quality Head

hace 4 semanas

Tres Cantos, España Merck 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**Equal Employment Opportunities**

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

**North America Disclosure**

If you are a resident of Colorado or New York City, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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