At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
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
Aufgaben
* Audit Planning & Execution:
o Plan and perform GMP/GDP Audits at Contract Manufacturing Organizations (CMOs) or Suppliers
o Prepare audit findings & reports and discuss potential impact on business
o Responsible for Follow-Up communication related to audits with CMOs & Suppliers and monitor CAPA
implementation related to audit findings
o Internal consultation for risk identification with day-to-day business & QA functions related to CMOs/Suppliers
* Quality Agreements:
o Support global and regional Quality Agreement template definition
o Negotiate Quality Agreements with CMOs and Suppliers
o Involve internal stakeholders in Quality Agreement negotiations whenever required
* Support Integrated Risk Management activities:
o Risk evaluation and re-classification of CMOs and Suppliers
o Score carding & metrics reports
* Support Due Diligence Activities
Profil
* 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
Wir bieten
* Excellent Benefits
* Work-Life Balance
* Growth and Development
* Health and Wellbeing Support
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