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.
Purpose of the function
For our Daiichi Sankyo Europe GmbH headquarters in Munich we are currently seeking highly qualified candidates to fill the position:
Senior Manager (m/f/d) Audit & Supplier Qualification
Roles and Responsibilities
- Audit Planning & Execution:
- Plan and perform GMP/GDP Audits at Contract Manufacturing Organizations (CMOs) or Suppliers
- Prepare audit findings & reports and discuss potential impact on business
- Responsible for Follow-Up communication related to audits with CMOs & Suppliers and monitor CAPA
implementation related to audit findings - Internal consultation for risk identification with day-to-day business & QA functions related to CMOs/Suppliers
- Quality Agreements:
- Support global and regional Quality Agreement template definition
- Negotiate Quality Agreements with CMOs and Suppliers
- Involve internal stakeholders in Quality Agreement negotiations whenever required
- Support Integrated Risk Management activities:
- Risk evaluation and re-classification of CMOs and Suppliers
- Score carding & metrics reports
- Support Due Diligence Activities
Personal skills and professional experience:
- Completed studies in the field of Pharmacy, Biology, Chemistry, or a comparable scientific discipline;
preferably diploma, master’s degree, or higher academic qualification - 5-8 years of relevant professional experience in a pharmaceutical company within the GMP area
- Extensive knowledge of international guidelines (like EudraLex Vol. 4, CFR 201/211, GAMP, etc.)
and experience in the practical application of GMP-regulations in the field of non-sterile/sterile
manufacturing of pharmaceutical products - Proven skills and experience as an auditor and in supplier qualification process in the pharmaceutical
industry – preferably as a Lead Auditor - Conscientious and independent working style and communication skills as required by ISO 19011
- Additional experience in guidelines such as ISO 9001, or DIN norms is a plus
- Auditor certification (e.g. CQI/IRCA, ASQ) is a plus
- Strong assertiveness and persistence
- Very good knowledge of TrackWise Digital or comparable QMS IT systems
- Very good English skills, both spoken and written
- High willingness to travel is an essential requirement
