(Senior) Global Quality Assurance Manager

vor 3 Wochen


Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:
Senior Quality Manager CMO (m/f/x) - Drug Product Manufacturing
In your new role you act as the primary contact for all quality related topics at contract manufacturing organizations (CMOs). 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
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
at least two years in Quality Assurance and/or Quality Management - preferable in Shop Floor QA activities or as QA Oversight for Manufacturing Activities for Sterile Manufacturing
at least two years in a GxP environment in a Fill&Finish manufacturing department for sterile solutions and/or lyophilisates
Excellent knowledge of international GMP/GDP regulations
Expertise in parenteral biological manufacturing particularly in the manufacture of sterile medicinal products or of biological active substances is desired
A true team player, high quality consciousness and a solution-oriented mindset
Very good written and verbal communication skills in English and German
Project management skills is a plus
Willingness to travel (up to 10%, domestic and international)



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