Lead Quality Assurance Manager CMO

vor 4 Wochen

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


Daiichi Sankyo is a global leader in pharmaceutical innovation, dedicated to enhancing patient care through cutting-edge solutions. With a rich history spanning over 120 years and a workforce of more than 17,000 professionals across 20 countries, we are committed to setting new benchmarks in healthcare.


Our European operations focus on two primary sectors: the Specialty Business, which aims to combat cardiovascular diseases, and Oncology, where we aspire to be at the forefront of pharmaceutical innovation by developing groundbreaking therapies for cancer patients.


Position Summary:


We are currently seeking a highly skilled individual for the role of Lead Quality Assurance Manager CMO (m/f/x). In this pivotal position, you will serve as the main point of contact for all quality-related matters concerning contract manufacturing organizations (CMOs) engaged in the production of small molecules.


Key Responsibilities:
  • Oversee quality management at CMOs, ensuring adherence to Daiichi Sankyo's quality standards (GMP/GDP) as outlined in quality agreements and regulatory requirements.
  • Address 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 monitor their timely execution.
  • Independently review, assess, and approve critical documents including Annual Product Quality Reviews (APQRs), Process Performance Qualification (PPQ) reports, and Continued Process Verification (CPV) documents.
  • Prepare and negotiate Quality Assurance Agreements (QAAs) with CMOs, ensuring compliance with Daiichi Sankyo's quality expectations.
  • Support CMOs during regulatory inspections and conduct audits on behalf of Daiichi Sankyo at various suppliers.
  • Identify and escalate quality risks at CMOs as necessary.

Global Collaboration:


In this role, you will act as a key information conduit within the Quality Assurance team and across other departments. Your responsibilities will include:

  • Assisting global teams and Subject Matter Experts (SMEs) in identifying and defining quality requirements for CMOs.
  • Disseminating quality-related information from CMOs to global stakeholders and vice versa, ensuring alignment and timely implementation of agreed-upon standards.
  • Contributing to the enhancement of the Daiichi Sankyo quality system and global Standard Operating Procedures (SOPs) through active participation in global working teams.
  • Providing support to regional QA functions for regulatory inquiries, including GMP clearance and import licensing.
  • Sharing expertise and knowledge within the Quality Assurance team and across other functions to improve CMO management.

Why Join Us?


At Daiichi Sankyo, we believe that working with us is more than just a job; it is an opportunity to make a meaningful impact on patients' lives. We are committed to fostering a culture of respect, continuous learning, and diversity. Here, you will have the chance to grow, innovate, and contribute your ideas in a supportive environment.


If you are passionate about quality assurance and dedicated to meeting the needs of patients, we invite you to explore this opportunity with us.

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