Head of Quality System Management

vor 1 Monat


Darmstadt, Deutschland Merck Group Vollzeit

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**

As the Head of Quality Systems Management within the R&D Quality Risk Management (RDQRM) organisation you will be responsible for developing, implementing and maintaining the R&D Quality Management System (QMS). You will proide leadership and strategic direction to support the achievement of R&D quality goals, ensuring that all research, development and quality processes comply with regulatory requirements, industry and company standards. You will drive continuous improvement and operational excellence across R&D functions and commercial subidiaries.

As a member of the global RDQRM leadership team, you will take up a critical management position within the quality organisation that is responsible for the worldwide risk-based strategy and the related oversight of the R&D Quality Management System.

In this role you will be responsible for:

- Quality Management System development and maintenance
- Regulatory Compliance
- Continuous improvement
- Controlled Documents & Training
- Risk Management
- Documentation and Records Management
- Collaboration and Communication
- Quality vendor management

**Who You Are**
- You have a Bachelor's degree in a scientific or engineering discipline. You ideally have a PhD or other higher level degree.
- You have a minimum of 10 years experience in quality assurance in the pharmaceutical, biotechnology or medical device industry with a focus on R&D.
- You have been responsible for quality on a global basis.
- You have in-depth knowledge or global regulatory requirements and industry standards, for example, GxP, ISO, ICH.
- You have experience of GLP, GCP and GPvP.
- You have demonstrable experience in management and development Quality Management Systems.
- You are a stong leader and team manager.
- You are an excellent communicator and problem solver with excellent analytical skills.

**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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