Purpose of the function

For our Daiichi Sankyo Europe GmbH headquarters in Munich we are currently seeking highly qualified candidates to fill the position:

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
  • You are 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 
  • As DS QA you independently review, evaluate and approve documents like APQRs, PPQ reports or CPVs 
  • The QA CMO is the person responsible for preparing and negotiating QAAs with CMOs and ensures the CMOs work in accordance with DS QAAs
  • You are involved in establishment of new manufacturing processes and site transfer activities and act as quality subject matter expert supporting PPQ and validation activities
  • You support CMOs during Authority Inspections and perform audits on behalf of DS at different suppliers as needed
  • In this role you identify quality risks at our CMOs and escalate issues in case it becomes necessary

• Act as global information distributor
  • In your new role you support global teams and SMEs to identify and define quality needs for CMOs
  • You share quality related information from the CMOs to our global stakeholders within the global QA environment as well as in department overarching meetings 

• Participate in the further development of the corporate QM-System
  • In global working teams you act as SME to improve the DS quality system and global SOP landscape
  • Share knowledge and expertise within QA or to other functions to improvement CMO management at DS

In this role you will work globally in close cooperation with other departments like 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