Quality Oversight Specialist

vor 2 Monaten

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

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.

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