Bei Daiichi Sankyo stehen wir vereint hinter einem einzigen Ziel: Das Leben auf der ganzen Welt durch innovative Medikamente zu verbessern. Mit aktiver Innovation seit 1899, Präsenz in mehr als 30 Ländern und über 19.000 Mitarbeitern entwickeln wir bahnbrechende Therapien in der Onkologie, für Herz-Kreislauf-Erkrankungen, seltene Krankheiten und Immunerkrankungen. Im Einklang mit unserer Vision 2030, "ein innovatives globales Gesundheitsunternehmen zu sein, das zur nachhaltigen Entwicklung der Gesellschaft beiträgt", gestalten wir eine gesündere, hoffnungsvollere Zukunft für Patienten, ihre Familien und die Gesellschaft.
For our Daiichi Sankyo Europe GmbH headquarters in Munich we are currently seeking highly qualified candidates to fill the position:
Expert (m/f/d) CMO Quality Management
As an Expert in CMO Quality Management, you will be a key player supporting the primary contact for quality-related topics at Contract Manufacturing Organizations (CMOs). Your role is essential in managing quality oversight at CMOs, ensuring the implementation and maintenance of Daiichi Sankyo's high-quality standards (GMP/GDP) and regulatory compliance for our oncology products. You will also collaborate across Daiichi Sankyo functions to support quality-related processes globally.
Roles and Responsibilities:
- Lead quality oversight activities at CMOs to ensure compliance with Daiichi Sankyo standards and international GMP guidelines
- Support and manage quality topics such as change control, deviations, and complaints related to Daiichi Sankyo products
- Monitor and track timely implementation and effectiveness of CAPAs linked to deviations or audit findings in collaboration with CMOs and internal stakeholders
- Review, evaluate, and approve critical quality documents including complaint investigations, deviation reports, and change controls, ensuring stakeholder involvement
- Assist CMO Quality Managers during authority inspections at supplier sites
- Collect and process quality data from CMOs according to internal SOPs, acting as a global information distributor
- Collaborate with global teams and subject matter experts to identify and define quality needs for CMOs
- Share quality-related information within global QA environments and cross-departmental meetings
- Contribute to the ongoing development of the corporate Quality Management System (QMS) and support global working teams in improving quality systems and SOP landscapes
- Work closely with departments such as Supply Chain, Technical Management, and Regulatory Affairs to ensure consistent supply of high-quality products to the market
Personal skills and professional experience:
- Bachelor’s degree in natural or pharmaceutical sciences with a minimum of 3 years relevant experience OR vocational training in pharmaceutical business with at least 6 years relevant experience
- Minimum 3 years professional experience in the pharmaceutical industry, including:
- At least 1 year in Quality Assurance and/or Quality Management, preferably with shop floor QA or QA oversight in manufacturing
- At least 2 years in a GxP environment in manufacturing or comparable roles
- Strong knowledge of international GMP/GDP regulations
- Assertive with excellent communication skills and a diplomatic approach during negotiations
- Team player with high quality consciousness and a solution-oriented mindset
- Fluent in English and German, both written and verbal
- Experience managing CMOs or external suppliers is advantageous
- Willingness to travel up to 10% domestically and internationally
