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Manager (m/f/x) QA QMS
Daiichi Sankyo Europe GmbH
Pfaffenhofen an der Ilm, Bavaria
Quality Assurance
Pharma
Data Processing
Trackwise Digital
Quality Management Systems
GxP
Passion for Innovation. Compassion for Patients.
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:
Manager (m/f/x) QA QMS
Purpose of the function:
In the new established role at Daiichi Sankyo Europe GmbH you act as the primary contact for all Quality Management System related topics.
As Manager QA QMS you support and manage all typical QA topics (like Deviations, Complaints, Change Control, Audits etc.) in our electronical QMS system (e.g., Trackwise Digital). Furthermore, you support the global Daiichi Sankyo QA group as an expert and window person in eQMS topics, processes and projects.
Roles and responsibilities:
- Manage QA topics in the existing local QMS:
- You are responsible for maintenance, updates etc. as an administrative function for the local eQMS
- Support in the creation and usage of KPIs and reports in the eQMS
- You are a window person between the existing QA systems and the eQMS in Trackwise Digital. In this role you support transfers from the existing QA systems to the eQMS
- Maintain global eQMS based on existing requirements
- As a window person you support projects for transferring and improving of existing local QA systems to a global system
- Participate in the further development of the corporate eQMS
- In global working teams you act as a SME to improve the eQMS on a local and global basis
- Share knowledge and expertise within QA or to other functions at DSE
In this role you will work in close cooperation with other departments and sites like the European Headquarter and the European affiliates as well as with other global regions to implement and to ensure a consistent eQMS.
Professional experience and personal skills:
- University/FH/Master degree or similar in Life Sciences (like Pharmacy, Biotechnology, Foodtechnology etc.)
- At least 3 years of relevant work experience in quality management in the pharmaceutical industry
- Several years of experience and knowledge in electronical Quality Management systems in the pharmaceutical industry
- Good knowledge of international GxP regulations
- Extensive knowledge of electronic data processing, especially in Quality Management (MS Office, Trackwise Digital, S4/Hana, SAP)
- A true teamplayer, high quality consciousness and a solution-oriented mindset
- Very good written and verbal communication skills in German and English
- Ability to work in interdisciplinary and international teams
- Structured and independent way of working
- Reliable, responsible and meticulous working style
- Project management skills is a plus
- Willingness to travel
Why work with us?
- Excellent Benefits
- Work-Life-Balance
- Growth and Development
- Health and Wellbeing Support
Working at Daiichi Sankyo:
Working at Daiichi Sankyo is more than just a job - it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
For more information: www.daiichi-sankyo.eu
Full-Time
, Permanent
Specialist
Updated at
09/05/2024
While applying for the job please refer to jobvector
Workplace
Job location
Luitpoldstraße 1
85276 Pfaffenhofen an der Ilm
Bavaria
Germany
Good to reach from...
- Augsburg
- Ingolstadt
- Freising
- Dachau
- Friedberg, Bayern
- Neuburg an der Donau
Salary
The value indicated here represents the average annual gross salary for comparable positions.
€ 67,122
About Daiichi Sankyo Europe GmbH
Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. The group’s 2025 vision is to become a “Global Pharma Innovator with Competitive Advantage in Oncology”. Our research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology. Our...
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