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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and...
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Senior Quality Manager CMO
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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and...
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Senior Quality Manager CMO
vor 2 Monaten
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and...
-
Senior Quality Manager CMO
vor 2 Monaten
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and...
Quality Oversight Specialist
vor 2 Monaten
About Daiichi Sankyo Europe
Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.
Job Summary
We are seeking a highly experienced Team Lead to join our Quality Assurance team in Munich, Germany. As a Team Lead, you will be responsible for managing a team of quality professionals responsible for ensuring the quality of our products manufactured by Contract Development and Manufacturing Organizations (CDMOs) in Europe.
Key Responsibilities
- Team Management
- Lead a team of 4-5 quality professionals responsible for quality oversight of CMOs in Europe
- Develop and implement strategies to optimize day-to-day business operations for the team
- Ensure that the team's expectations are met by internal and external stakeholders
- Quality Oversight
- Work closely with global QA, CMC, Regulatory Affairs, and Supply Chain functions to support the team in solving challenges related to CMO management
- Review and evaluate documents such as APQRs, PPQ reports, and CTDs as required
- Support the organization during Authority Inspections in your area of responsibility and perform audits on behalf of DS at different suppliers as needed
- Information Distribution
- Monitor quality-related information from different markets to ensure early recognition of trends related to your area of responsibility
- Provide such information to global teams and SMEs to identify quality-related risks at an early stage and support on every level to find suitable mitigation measures
- QM-System Development
- Act as a Subject Matter Expert (SME) to help improve the global Daiichi-Sankyo Quality Management System (QMS) and global SOP landscape
- Share knowledge and expertise within the DS network to improve QA and CMO management at DS
Requirements
- Education
- University/FH/Master degree in natural or pharmaceutical sciences - preferred in Pharmacy, Biotechnology, Biology, or a comparable program
- Experience
- At least 8+ years of relevant work experience in the pharmaceutical industry, including:
- At least 4+ years in Quality Assurance and/or Quality Management - preferable in different functions such as Shop Floor QA, QA Oversight for Manufacturing Activities, and/or global QA roles
- At least 2+ year experience of working in a GMP in manufacturing for monoclonal anti-bodies and/or biological APIs
- Experience with ADC manufacturing is a strong plus
- Leadership Experience
- At least 4+ years experience as a team leader with at least 4-5 direct reports
- Skills
- Excellent knowledge of international GMP/GDP regulations
- Experience in managing relationships with C(D)Mos or external supplier organizations
- Proven track record of Project management and Leadership skills in Matrix Organizations is beneficial
- Very good knowledge of CMC regulatory and development - relevant work experience in these fields is a plus
- Have assertiveness, strong communication skills paired with diplomatic attitude during negotiations
- A true team player, high quality consciousness, and a solution-oriented mindset
- 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
- Willingness to travel (up to 10%, domestic and international)
Why Work with Us?
At Daiichi Sankyo Europe, we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. We offer a dynamic and challenging 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.
