Head of Quality Assurance for CMO

vor 4 Wochen

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

About the Role: In the field of Oncology, our mission is to emerge as a leading global pharmaceutical innovator, dedicated to developing groundbreaking therapies for cancer patients.

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

Key Responsibilities:

  • Act as the primary liaison for quality topics with CMOs.
  • Provide expert support to various Daiichi Sankyo functions regarding quality processes.
  • Participate in the establishment of new manufacturing processes and facilitate site transfer activities.
  • Serve as a quality subject matter expert during PPQ and validation activities.
  • Support CMOs during regulatory inspections and conduct audits on behalf of Daiichi Sankyo as required.
  • Disseminate critical quality information globally.
  • Collaborate with global teams and subject matter experts to identify and define quality requirements for CMOs.
  • Share quality-related insights from CMOs with global stakeholders within the QA framework and during departmental meetings.
  • Contribute to global working teams as a subject matter expert to enhance the Daiichi Sankyo quality system and global SOP landscape.
  • Facilitate knowledge sharing within QA and across 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 activities or QA Oversight for Manufacturing Activities in Sterile Manufacturing.
  • At least two years of experience in a GxP environment within a Fill & Finish manufacturing department for sterile solutions and/or lyophilisates.
  • Comprehensive knowledge of international GMP/GDP regulations.
  • Expertise in parenteral biological manufacturing, particularly in the production of sterile medicinal products or biological active substances is preferred.
  • Excellent written and verbal communication skills in both English and German.
  • Project management experience is advantageous.
  • Willingness to travel up to 10%, both domestically and internationally.

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