Quality Assurance Manager CMO
vor 2 Monaten
About Daiichi Sankyo Europe
Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.
Our Mission
We strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and protecting people from cardiovascular disease, the leading cause of death in Europe.
Job Summary
We are seeking a highly qualified Senior Quality Manager CMO to join our team in Munich, Germany. As a key member of our Quality Assurance team, you will be responsible for managing quality oversight at Contract Manufacturing Organizations (CMOs), ensuring compliance with regulatory requirements and company standards.
Key Responsibilities
- Manage quality oversight at CMOs, including change control, deviations, and complaints related to manufacturing of Daiichi Sankyo products.
- Define and implement effective Corrective Action Preventive Action (CAPA) plans with CMOs and track timely implementation.
- Review, evaluate, and approve documents such as Audits, Process Validation Reports, and Change Control Records.
- Negotiate and prepare Quality Agreements with CMOs, ensuring compliance with Daiichi Sankyo's quality standards.
- Support CMOs during Authority Inspections and perform audits on behalf of Daiichi Sankyo at different suppliers.
- Identify quality risks at CMOs and escalate issues as necessary.
- Act as a global information distributor within Quality Assurance and to other departments, sharing quality-related information and best practices.
- Support global and regional Quality Assurance functions, improving the Daiichi Sankyo quality system and global SOP landscape.
Requirements
To be successful in this role, you will need:
- Strong knowledge of quality management systems, regulatory requirements, and industry standards.
- Excellent communication and negotiation skills, with the ability to work effectively with cross-functional teams and external partners.
- Proven experience in quality assurance, with a focus on CMO management and regulatory compliance.
- Ability to work independently and as part of a global team, with a strong commitment to continuous learning and improvement.
Why Work with Us?
At Daiichi Sankyo Europe, we foster a culture of mutual respect, continuous learning, and inclusion. We offer a dynamic and challenging work environment, with opportunities for growth and development. If you have a passion for quality and a commitment to excellence, we encourage you to apply for this exciting opportunity.
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