Global Quality Assurance Lead

vor 4 Wochen

Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

Company Overview: At Daiichi Sankyo Europe GmbH, we are dedicated to becoming a leading innovator in the pharmaceutical industry, focusing on developing groundbreaking therapies for cancer treatment.

Position Summary: We are currently looking for a qualified professional to join our team as a Senior Quality Manager CMO (m/f/x) - Drug Product Manufacturing. In this pivotal role, you will serve as the primary liaison for all quality-related matters concerning contract manufacturing organizations (CMOs).

Key Responsibilities:

  • Act as the main point of contact for quality assurance topics at CMOs.
  • Provide expert support to various Daiichi Sankyo functions regarding quality processes.
  • Participate in the establishment of new manufacturing processes and oversee site transfer activities.
  • Serve as a quality subject matter expert, particularly in supporting PPQ and validation activities.
  • Assist CMOs during regulatory inspections and conduct audits on behalf of Daiichi Sankyo as necessary.
  • Facilitate the distribution of quality-related information to global stakeholders within the QA framework.
  • Collaborate with global teams to identify and articulate quality requirements for CMOs.
  • Contribute to the enhancement of the Daiichi Sankyo quality system and global SOP landscape.
  • Share knowledge and expertise within the QA department and other functions to improve CMO management.

Qualifications:

  • A minimum of two years of experience in Quality Assurance and/or Quality Management, preferably in Shop Floor QA or QA Oversight for Sterile Manufacturing Activities.
  • At least two years of experience in a GxP environment within a Fill & Finish manufacturing department for sterile solutions and/or lyophilisates.
  • Comprehensive understanding of international GMP/GDP regulations.
  • Desired expertise in parenteral biological manufacturing, particularly in sterile medicinal products or biological active substances.
  • Excellent written and verbal communication skills in both English and German.
  • Project management skills are an advantage.
  • Willingness to travel domestically and internationally (up to 10%).

Join us in our mission to innovate and improve the lives of patients worldwide.

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