Team Lead

Vor 6 Tagen

Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

About the Role:

We are seeking a highly qualified Team Lead to join our Quality Assurance team at Daiichi Sankyo Europe. As a Team Lead, you will be responsible for managing a team of quality professionals responsible for overseeing the quality of our Contract Manufacturing Organizations (CMOs) in Europe.

Key Responsibilities:

  • Manage a team of 4-5 quality professionals responsible for quality oversight of CMOs in Europe
  • Work closely with global QA, CMC, Regulatory Affairs, and Supply Chain functions to ensure seamless quality operations
  • Develop and implement strategies for optimal day-to-day business operations for the team
  • Ensure expectations from internal and external stakeholders are met
  • Develop and lead team members on a personal and professional level
  • Interact with management level at CMOs and take on quality-related topics as needed
  • Review and evaluate documents such as APQRs, PPQ reports, and CTDs
  • Support the organization during Authority Inspections and perform audits on behalf of DS at different suppliers as needed
  • Act as a global information distributor, monitoring quality-related information from different markets and providing insights to global teams and SMEs
  • Participate in the further development of the corporate QM-System and share knowledge and expertise within the DS network

Requirements:

  • University degree in natural or pharmaceutical sciences, preferably in Pharmacy, Biotechnology, Biology, or a comparable program
  • At least 8+ years of relevant work experience in the pharmaceutical industry, including 4+ years in Quality Assurance and/or Quality Management
  • At least 2+ years of experience working in a GMP manufacturing environment for monoclonal antibodies and/or biological APIs
  • Experience with ADC manufacturing is a strong plus
  • At least 4+ years of experience as a team leader with 4-5 direct reports
  • 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
  • Very good knowledge of CMC regulatory and development
  • Assertiveness, strong communication skills, and a diplomatic attitude during negotiations
  • A true team player, high quality consciousness, and a solution-oriented mindset
  • 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)

About Daiichi Sankyo Europe:

Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. We are committed to fostering a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. We offer a dynamic and challenging work environment that allows our employees to grow, think boldly, and contribute their ideas.

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