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