Quality Strategy Lead

vor 5 Monaten

Darmstadt, Deutschland Merck KGaA 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**:
**Responsibilities**
- Manage due diligence processes for asset transfer, in/ out licensing, and other business development activities including the actual transition upon successful deal with regards to quality assurance
- Collaborate with cross-functional teams to assess data transfer plans and mitigate quality risks associated with asset transfers and licensing agreements.
- Work closely with the project/program teams and being accountable for establishing the quality strategy in support of the assigned program and to utilize/develop RDQRM tools to deliver the strategy
- Conduct quality assurance activities to ensure compliance with regulatory standards and industry best practices.
- Utilize data analytical skills to interpret and analyze quality-related data and trends.
- Implement continuous improvement initiatives to enhance quality processes and systems. Contribute to the development and maintenance of quality management systems.

**Who you are:
- Bachelor's degree in a relevant scientific field; advanced degree preferred.
- Minimum of 10 years of experience in quality assurance within the pharmaceutical or healthcare industry with focus on ICH GCP.
- Strong knowledge/ experience of due diligence processes related to asset transfer, in/ out licensing, and business development.
- Proven analytical skills with a keen interest in data analysis and interpretation.
- Agile, adaptable, and curious mindset with a commitment to driving quality excellence.
- Proven ability to function autonomously at a senior level in a matrix model and in a team environment Fluent in written and spoken English

Position can be located in any European location

**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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