Senior Quality Manager CMO - Drug Substance Manufacturing - 70000798

Bei Daiichi Sankyo stehen wir vereint hinter einem einzigen Ziel: Das Leben auf der ganzen Welt durch innovative Medikamente zu verbessern. Mit aktiver Innovation seit 1899, Präsenz in mehr als 30 Ländern und über 19.000 Mitarbeitern entwickeln wir bahnbrechende Therapien in der Onkologie, für Herz‑Kreislauf‑Erkrankungen, seltene Krankheiten und Immunerkrankungen. Im Einklang mit unserer Vision 2030, "ein innovatives globales Gesundheitsunternehmen zu sein, das zur nachhaltigen Entwicklung der Gesellschaft beiträgt", gestalten wir eine gesündere, hoffnungsvollere Zukunft für Patienten, ihre Familien und die Gesellschaft.

Senior Quality Manager CMO (m/f/x) Antibody Drug Conjugate (ADC) Manufacturing

As Senior Quality Manager CMO, you will serve as the primary contact for all quality‑related matters at Contract Manufacturing Organizations (CMOs). You will be responsible for managing quality oversight at CMOs, ensuring the implementation and maintenance of Daiichi Sankyo’s quality standards (GMP/GDP) and regulatory requirements for our oncology products. Additionally, you will support various Daiichi Sankyo functions as a subject‑matter expert in quality topics and processes.

Roles And Responsibilities

• Manage quality oversight at CMOs
  • Responsible for quality related topics like change controls, deviations and complaints related to DS products at CMOs
  • Define together with the CMO effective CAPAs and track the timely implementation
  • Independently review, evaluate and approve documents such as APQRs, PPQ reports or CPVs
  • Responsible for preparing and negotiating QAAs with CMOs and ensuring the CMOs work in accordance with DS QAAs
  • Involved in establishment of new manufacturing processes and site transfer activities and act as quality subject‑matter expert supporting PPQ and validation activities
  • Support CMOs during Authority Inspections and perform audits on behalf of DS at different suppliers as needed
  • Identify quality risks at our CMOs and escalate issues if necessary
• Act as global information distributor
  • Support global teams and SMEs to identify and define quality needs for CMOs
  • Share quality related information from the CMOs to our global stakeholders within the global QA environment and in department overarching meetings
• Participate in the further development of the corporate QM‑System
  • Act as SME in global working teams to improve the DS quality system and global SOP landscape
  • Share knowledge and expertise within QA or to other functions to improve CMO management at DS

In this role you will work globally in close cooperation with other departments such as Supply Chain, CMC, regulatory functions and others to ensure consistent supply to markets with products which meet our high quality standards at any time.

Personal Skills And Professional Experience

• University/FH or Master’s degree in natural or pharmaceutical sciences, preferably in Biotechnology, Bioengineering, Biochemistry, or a related field
• Minimum of five years relevant experience in the pharmaceutical industry, including:
  • At least two years in Quality Assurance and/or Quality Management, preferably in Shop Floor QA activities or QA Oversight for GMP operations
  • At least two years working in a GMP environment within an ADC manufacturing setting, focusing on chemical components and bioconjugation
• Strong knowledge of international GMP/GDP regulations
• Expertise in ADC product manufacturing is highly desirable
• Assertive with excellent communication and negotiation skills paired with a diplomatic approach
• A true team player with a strong quality mindset and a solution‑oriented approach
• Proficient in written and verbal English and German communication
• Experience managing CMOs or external suppliers is beneficial
• Project management skills are a plus
• Willingness to travel up to 10% domestically and internationally