Passion for Innovation. Compassion for Patients.
With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.
In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.
Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.
For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:
Expert (m/f/x) CMO Quality Management
Purpose of the function:
In your new role you support the primary contact for quality related topics (CMO-MQ) at contract manufacturing organizations (CMOs). You support the management of the quality oversight at the CMOs, which includes the implementation and maintaining of DS quality standards (GMP/GDP) and regulatory requirements for our oncology products. Furthermore, you support other DS functions in quality-related topics and processes.
Manage quality oversight at CMOs
You support the responsible person for quality related topics like change control, deviations and/or complaints related to DS products at CMOs and process independently assigned tasks
You track the timely implementation of CAPAs related to deviations or audit findings and check the effectiveness in collaboration with the CMO and internal stakeholders
You review, evaluate and approve documents like complaint investigations, deviation reports or change controls and ensure relevant stakeholders are included whenever necessary
You ensure the CMO operates in compliance to the established QAA and international GMP guidelines
You support CMO-MQs during Authority Inspections at different suppliers as needed
You collect data from CMOs and process the data as described per internal SOPs
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 whenever necessary
Participate in the further development of the corporate QM-System
You support global working teams to improve the DS quality system and global SOP landscape
In this role you will work globally in close cooperation with other departments like Supply Chain, Tech Management, Regulatory Affairs functions and others to ensure consistent supply to markets with products which meet our high-quality standards at any time.
Bachelor degree in natural or pharmaceutical sciences with at least 3 years relevant professional experience or OR vocational training in pharmaceutical business with at least 6 years relevant professional experience
At least 3 years of relevant work experience in the pharmaceutical industry including:
at least 1 years in Quality Assurance and/or Quality Management - preferable in Shop Floor QA activities or as QA Oversight for Manufacturing Activities
at least 2 years in a GxP environment in a position involved in manufacturing or comparable activities
Excellent knowledge of international GMP/GDP regulations
Have assertiveness, strong communication skill paired with 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 and German
Experience with managing CMOs or external suppliers is beneficial
Willingness to travel (up to 10%, domestic and international)
Excellent Benefits
Work-Life-Balance
Growth and Development
Health and Wellbeing Support