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Senior Manager of Quality Assurance

vor 2 Monaten


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

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

Position Overview: We are currently looking for a Senior Quality Manager CMO (m/f/x) - Drug Product Manufacturing. In this pivotal role, you will serve as the main point of contact for all quality-related matters concerning contract manufacturing organizations (CMOs).

Key Responsibilities:

  • Act as the primary liaison 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 during process performance qualification (PPQ) and validation activities.
  • Support CMOs during regulatory inspections and conduct audits on behalf of Daiichi Sankyo at various suppliers as required.
  • Disseminate critical quality information globally.
  • Collaborate with global teams and subject matter experts to identify and define quality requirements for CMOs.
  • Facilitate the sharing of quality-related information from CMOs to our global stakeholders within the quality assurance framework.
  • Contribute to the enhancement of the Daiichi Sankyo quality system and global standard operating procedures (SOPs).
  • Share knowledge and expertise within the quality assurance 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 quality assurance activities or as quality oversight for manufacturing processes.
  • At least two years of experience in a GxP environment, specifically within a fill and finish manufacturing department for sterile solutions and/or lyophilisates.
  • Strong understanding of international GMP/GDP regulations.
  • Desirable expertise in parenteral biological manufacturing, particularly in the production of sterile medicinal products or biological active substances.
  • Excellent verbal and written communication skills in both English and German.
  • Project management skills are advantageous.
  • Willingness to travel up to 10%, both domestically and internationally.