Rdq Quality Strategy Lead
Vor 7 Tagen
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**:
The RDQ Quality Strategy Lead (all genders) Development will be mainly responsible for managing clinical programs day to day activities from quality assurance perspective and delivering the full range of quality related activities in support of the program. The incumbent works closely with the project/program teams and is accountable for establishing the quality assurance strategy in support of the program and to utilize/develop RDQ tools to deliver the strategy. You will lead multidisciplinary or cross-functional work/project teams and actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems. You will be responsible to lead inspection preparedness activities in the cross-functional teams and partners for assigned trials/programs as part of the planned regulatory submission in different Countries/authorities (China, EU, US, Japan, etc). Strong technical expertise is a must as you will additionally lead complex projects, involve in due diligence (DD) as quality expert, and coach and mentor other colleagues in our field of Research & Development (R&D).
**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. Experience in medical device clinical trials is a plus.
- Experience in leading inspection readiness or inspection preparation activities. Experience in inspection management and response is a plus.
- Knowledge/ experience of due diligence processes related to asset transfer, in/ out licensing, and business development preferred.
- 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 all EU countries
**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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