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Global director • reichertshausen
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Biologist as Quality Manager (m / f / d)
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ARaymond NetworkLÖRRACH, Germany.Biologist as Quality Manager (m / f / d)
Daiichi Sankyo Europe GmbHPfaffenhofen an der Ilm, Bayern, GermanyPassion 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 our site in Pfaffenhofen / Ilm we are seeking qualified candidates to fill the position :
Senior) Quality Manager (m / f / x) CMO
Purpose of the function :
In your new role you act as the primary contact for all quality related topics at contract manufacturing organizations (CMOs) involved in the manufacturing of small molecules. You manage the quality oversight at the assigned CMO / manufacturing site, which include implementation and maintaining of Daiichi-Sankyo quality standards (GMP / GDP) as described per quality agreements and international regulatory requirements. Furthermore, you support other DS functions as an expert in quality related topics and processes and support the global organization in product oversight.
Roles and Responsibilities
- Manage quality oversight at CMO / manufacturing site, including
Handling of quality related topics like change control, deviations and / or complaints related to manufacturing of DS products at CMOs
In your new role you support local and global teams and SMEs to identify and define quality needs for CMOs
In global working teams you act as SME to improve the DS quality system and global SOP landscape
In this role you will work regionally and 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 :
Why work with us?