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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeWe are a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we strive to become a global pharma innovator with competitive advantage.Job SummaryWe are seeking a highly qualified...
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Senior Quality Manager CMO
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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeWe are a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With over 120 years of experience and a presence in over 20 countries, we strive to become a global pharma innovator with competitive advantage.Job SummaryWe are seeking a highly qualified...
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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitPassion for Innovation. Compassion for Patients.Dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world, Daiichi Sankyo is a leading pharmaceutical company with over 120 years of experience and more than 17,000 employees in over 20 countries.In Europe, we focus on two areas: protecting...
Product Owner Quality Specialist
vor 2 Monaten
We are seeking a highly qualified candidate to fill the position of Product Owner Quality at Daiichi Sankyo Europe GmbH.
About the Role:The Product Owner Quality will be responsible for managing global quality oversight for assigned products, working closely with different functions from global QA, CMC, Regulatory Affairs, and Supply Chain in a matrix organization.
Key Responsibilities:- Manage global quality oversight for assigned products, including reviewing and evaluating documents like APQRs, PPQ reports, or CTDs.
- Act as a global information distributor, monitoring quality-related information from different markets and clinical studies to ensure a consistent global understanding of assigned products.
- Participate in the further development of the corporate QM-System, acting as a SME to help improve the global Daiichi-Sankyo QMS and global SOP landscape.
- University/FH/Master degree in natural or pharmaceutical sciences, preferably in Pharmacy, Biotechnology, Microbiology, or a comparable program.
- At least 8+ years of relevant work experience in the pharmaceutical industry, including at least 4+ years in Quality Assurance and/or Quality Management.
- Excellent knowledge of international GMP/GDP regulations.
- Proven track record of Project management and Leadership skills.
- Very good knowledge of CMC regulatory and development, relevant work experience in these fields is a plus.
At Daiichi Sankyo, we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. We offer a dynamic work environment where you can grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.