Lead Quality Assurance Manager CMO

vor 3 Wochen

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

Passion for Innovation. Compassion for Patients.

With a rich legacy spanning over 120 years and a dedicated workforce of more than 17,000 across 20 countries, Daiichi Sankyo is committed to pioneering, developing, and delivering innovative healthcare solutions that enhance the quality of life globally.

In Europe, our focus is twofold: our Specialty Business aims to combat cardiovascular diseases, the leading cause of mortality in the region, while in Oncology, we aspire to be a global leader in pharmaceutical innovation, developing groundbreaking therapies for cancer patients.

Position Overview:

We are currently seeking a highly skilled professional for the role of Lead Quality Assurance Manager CMO (m/f/x).

Key Responsibilities:

  • Quality Oversight Management: Serve as the primary liaison for all quality-related matters at contract manufacturing organizations (CMOs) engaged in the production of small molecules. You will oversee the implementation and maintenance of Daiichi Sankyo's quality standards (GMP/GDP) in accordance with quality agreements and international regulatory guidelines.
  • Quality Assurance Expertise: Manage quality-related issues such as change control, deviations, and complaints associated with the manufacturing of Daiichi Sankyo products at CMOs. Collaborate with CMOs to establish effective corrective and preventive actions (CAPAs) and ensure their timely execution.
  • Documentation Review: Independently assess and approve critical documents including Annual Product Quality Reviews (APQRs), Process Performance Qualification (PPQ) reports, and Continued Process Verification (CPV) reports.
  • Quality Agreement Negotiation: Prepare and negotiate Quality Assurance Agreements (QAAs) with CMOs, ensuring compliance with Daiichi Sankyo's quality standards.
  • Regulatory Support: Assist CMOs during regulatory inspections and conduct audits on behalf of Daiichi Sankyo at various suppliers. Identify potential quality risks at CMOs and escalate issues as necessary.

Global Collaboration:

In this role, you will support global teams and subject matter experts (SMEs) in identifying and defining quality requirements for CMOs. You will facilitate the flow of quality-related information between CMOs and global stakeholders within the quality assurance framework.

Support for QA Functions:

Act as a subject matter expert in global working teams to enhance the Daiichi Sankyo quality system and global standard operating procedures (SOPs). Provide support to regional QA functions for regulatory inquiries, including GMP clearance and import licensing.

Cross-Departmental Collaboration:

Work closely with various departments such as Supply Chain, Chemistry, Manufacturing, and Controls (CMC), and regulatory functions to ensure a consistent supply of products that meet our stringent quality standards.

Why Join Us?

At Daiichi Sankyo, your role transcends traditional job functions; it is an opportunity to make a meaningful impact on patients' lives. We cultivate a culture of mutual respect and continuous learning, emphasizing inclusion and diversity. Here, you will have the chance to grow, innovate, and share your insights.

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