Senior Quality Manager CMO

vor 6 Stunden

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

Passion for Innovation. Compassion for Patients.

Daiichi Sankyo Europe is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

We are seeking a highly qualified candidate to fill the position of Senior Quality Manager CMO (m/f/x) – Drug Product Manufacturing.

Purpose of the function:

The Senior Quality Manager CMO will be responsible for managing quality oversight at Contract Manufacturing Organizations (CMOs). This includes defining effective Corrective Action Preventive Action (CAPA) plans and tracking their timely implementation. The QM CMO will also review, evaluate, and approve documents such as Annual Product Quality Reports (APQRs), Process Performance Qualification (PPQ) reports, and Certificate of Pharmaceutical Products (CPVs).

Roles and responsibilities:

  • Manage quality oversight at CMOs, including change control, deviations, and complaints related to Daiichi Sankyo products.
  • Define effective CAPAs and track their timely implementation.
  • Review, evaluate, and approve documents such as APQRs, PPQ reports, and CPVs.
  • Prepare and negotiate Quality Agreements (QAAs) with CMOs and ensure they work in accordance with Daiichi Sankyo's Quality Agreements.
  • Support the establishment of new manufacturing processes and site transfer activities.
  • Act as a quality subject matter expert supporting PPQ and validation activities.
  • Support CMOs during Authority Inspections and perform audits on behalf of Daiichi Sankyo at different suppliers as needed.
  • Identify quality risks at CMOs and escalate issues as necessary.
  • Act as a global information distributor, supporting global teams and Subject Matter Experts (SMEs) to identify and define quality needs for CMOs.
  • Share quality-related information from CMOs to global stakeholders within the global QA environment and in department-overshadowing meetings.
  • Participate in the further development of the corporate Quality Management (QM) System.
  • Act as a SME to improve the Daiichi Sankyo quality system and global SOP landscape.
  • Share knowledge and expertise within QA or to other functions to improve CMO management at Daiichi Sankyo.

In this role, you will work globally in close cooperation with other departments such as Supply Chain, CMC, regulatory functions, and others to ensure consistent supply to markets with products that meet our high quality standards at any time.

Personal skills and professional experience:

  • University/FH/Master degree in natural or pharmaceutical sciences, preferably in Pharmacy, Biotechnology, Microbiology, or a comparable program.
  • At least five years of relevant work experience in the pharmaceutical industry, including:
  • At least two years in Quality Assurance and/or Quality Management, preferably in Shop Floor QA activities or as QA Oversight for Manufacturing Activities for Sterile Manufacturing.
  • At least two years in a GxP environment in a Fill&Finish manufacturing department for sterile solutions and/or lyophilisates.
  • Excellent knowledge of international GMP/GDP regulations.
  • Expertise in parenteral biological manufacturing, particularly in the manufacture of sterile medicinal products or biological active substances, is desired.

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