Product Owner Quality Specialist
vor 2 Wochen
About the Role:
We are seeking a highly qualified Product Owner Quality to join our team at Daiichi Sankyo Europe GmbH. As a global quality lead, you will be responsible for managing quality oversight for assigned products, working closely with global QA, CMC, Regulatory Affairs, and Supply Chain teams to define strategic approaches to solve challenges in the day-to-day business.
Key Responsibilities:
- Manage global quality oversight for assigned products, including reviewing and evaluating documents like APQRs, PPQ reports, and 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, sharing knowledge and expertise within the DS network to improve QA and CMO management at DS.
Requirements:
- 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, preferably in different functions such as Shop Floor QA activities, QA Oversight for Manufacturing Activities, and/or global QA roles.
- 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 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).
Why Work with Us?
At Daiichi Sankyo, we are dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. We foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
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