Jobbeschreibung
With over 120 years of experience and more than 17,000 employees in over 20 countries, 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 strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:
Senior Quality Manager CMO (m/f/x)
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 CMOs, 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.
- Manage quality oversight at CMOs
- You are responsible for quality related topics like change control, deviations and/or complaints related to manufacturing of 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
- You are responsible for preparing and negotiating QAAs with CMOs and ensure the CMOs work in accordance with DS QAAs
- You support CMOs during Authority Inspections and perform audits on behalf of DS at different suppliers
- In this role you additionally identify quality risks at our CMOs and escalate issues in case it becomes necessary
- Act as global information distributor within QA and to other departments
- 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
- You provide information from global stakeholders to the CMO and ensure timely implementation of agreed requirements
- Act as support for global and regional QA functions
- In global working teams you act as SME to improve the DS quality system and global SOP landscape
- Support regional QA functions for regulatory requests regarding e.g. GMP clearance or import license
- 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.
- Excellent Benefits
- Work-Life Balance
- Growth and Developement
- Health and Wellbeing Support