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Site Quality Head

hace 20 horas

Naucalpan, México Merck Group 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.

The Site Quality Head will be responsible for leading all quality assurance (QA) and quality control (QC), and quality management system (QMS) activities at the site, ensuring compliance with pharmaceutical industry regulations and the company’s internal standards. This role is crucial in maintaining the safety, efficacy, and regulatory compliance of manufactured products while fostering a quality-driven environment that promotes continuous improvement.

**Your Role**
- Oversee QA and QC operations to ensure all products meet established quality standards.
- Implement and maintain the Quality Management System (QMS) in accordance with GMP (Good Manufacturing Practices), ISO, FDA, ANVISA, and other local and international regulations, and company standards.
- Ensure ongoing compliance with all relevant pharmaceutical industry regulations and guidelines.
- Lead internal and external audits, and manage responses to regulatory inspections.
- Develop and implement quality policies and procedures to enhance the efficiency and effectiveness of manufacturing processes.
- Promote continuous improvement initiatives to elevate product quality and compliance.
- Lead and develop the QA, QMS, and QC teams, fostering a collaborative and results-oriented work environment.
- Identify training and development needs to ensure the team possesses the necessary competencies to meet company requirements and maintain quality standards.
- Assess and mitigate risks associated with product quality and manufacturing processes.
- Manage changes in manufacturing processes and the QMS, ensuring all modifications are evaluated and approved according to internal procedures.
- Prepare and present quality performance reports to the Global Quality Director and other stakeholders.
- Facilitate effective communication between departments to ensure an integrated approach to quality management.

**Who you are**
- Education: Bachelor’s degree in Pharmacy, Chemical Engineering, Biotechnology, or related fields. Master’s degree or specialization in Quality Management or related areas is preferred.
- Experience: Minimum of 8-10 years of experience in quality roles within the pharmaceutical industry, with at least 5 years in a leadership position. Working knowledge of regulatory requirements.
- Knowledge: Deep understanding of pharmaceutical industry regulations, including GMP, FDA, and ISO. Experience with audits and regulatory inspections.
- Skills: Excellent leadership and team management skills. Strong problem-solving and decision-making abilities. Effective communication skills, both verbal and written.


**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