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.
We are seeking a highly qualified candidate to fill the position:
Regional Process Lead
(m/f/x)
eQMS
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Roles and Responsibilities:
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Regional accountability for overseeing and enhancing eQMS system processes to ensure operational efficiency and transparency
Drive standardization of the assigned system processes – both in the area of GMP and GDP
Collaborate closely with the regional Business Process Owner
Continuously monitor process performance and derive measures for process improvement in close cooperation with various global and regional stakeholders
Support implementation of best practice standards and ensure compliance with quality and regulatory requirements in your own area of responsibility
Collaborate closely with global Process Leads and actively contribute to shaping global eQMS system
Ensure continuous operational readiness of system processes by maintaining up-to-date documentation, including procedures, templates, and work instructions within DSE
Develop and deliver training for employees for the assigned system processes
Personal skills and professional experience:
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Completed studies in natural sciences / pharmaceutical sciences or a comparable qualification
5+ years of relevant professional experience in a GMP/GDP-regulated environment
Experience with electronic QM systems (e.g., TrackWise Digital, Veeva Quality Vault, etc.)
Experience with computer system validation is a plus
Excellent communication skills and experience in stakeholder management
Strong analytical skills and attention to detail, with the ability to communicate complex matters/concepts to various stakeholders
Very good knowledge of relevant regulations from various authorities (e.g., EMA, SwissMedic, MHRA, Health Canada, etc.)
Excellent German and English skills, both written and spoken
Why work with us?
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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
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