Jobbeschreibung
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
- 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
- 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
- Excellent Benefits
- Work-Life Balance
- Growth and Development
- Health and Wellbeing Support