Director, Quality Strategy Lead Vendor

Vor 7 Tagen

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**:
We are seeking a Quality Strategy Lead Vendor for our Healthcare R&D Quality and Risk Management team. You will be responsible for developing and maintaining a global GxP compliant strategy for vendor quality oversight. This includes managing the vendor audit and assessment program, prioritizing tasks using a risk-based approach, tracking deliverables, and identifying issues. You will develop quality tools, conduct reviews, and ensure our approach adapts to regulatory changes while supporting inspection readiness and relationship management with quality counterparts across R&D teams and vendors.

**Who You Are**:

- University degree required; advanced degree preferred.
- Minimum 15 years of clinical development including QA experience in pharmaceutical/biotech sectors, ideally also in CROs.
- Strong knowledge of Quality, Data Integrity, and QA principles.
- In-depth knowledge of vendor and third-party vendor quality management, including risk management processes.
- Comprehensive knowledge of GxP and other compliance regulations. GxP auditing experience is a plus.
- Proven ability to work autonomously in a matrix environment.
- Strong analytical, critical thinking, and communication skills.
- Fosters open dialogue and demonstrates cultural sensitivity.

This position is open globally, preferably in European locations.

**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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