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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.
Job Summary:The successful candidate will be responsible for managing global quality oversight for assigned products, working closely with various functions to define strategic approaches to solve challenges in the day-to-day business. This includes reviewing and evaluating documents, trending product development from a quality-related perspective, and identifying quality risks.
Key Responsibilities:- Manage global quality oversight for assigned products, working closely with global QA, CMC, Regulatory Affairs, and Supply Chain teams.
- Review and evaluate documents such as APQRs, PPQ reports, and CTDs.
- Trend product development from a quality-related perspective and keep senior management and the team informed about developments.
- Identify quality risks related to assigned products and escalate issues to senior level management as necessary.
- Support the organization during submissions in GMP-related matters and during Authority Inspections related to assigned products.
- 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.
- Support global teams and SMEs to identify quality-related risks at an early stage and support the development of mitigation measures.
- 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, and at least 2+ years of experience working in a GMP environment in a Fill&Finish manufacturing department for sterile solutions and/or lyophilisates or in manufacturing for biological APIs.
- 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.
- Expertise in Supply Chain and global demand planning is desired.
- Have assertiveness, strong communication skills paired with a diplomatic attitude during negotiations.
- A true team player, high quality consciousness, and a solution-oriented mindset.
- Combine a "Hands-on" mentality with strategic thinking.
- Manage senior level relationships within the company and with external partners.
- Very good written and verbal communication skills in English.
- Japan and/or German communication skills is a plus.
- Experience with managing CMOs or external suppliers is beneficial.
- Willingness to travel (up to 10%, domestic and international).
Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients' lives for the better. We foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to 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.
