Senior Quality 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 department, you will be responsible for managing quality oversight at Contract Manufacturing Organizations (CMOs) and ensuring that our products meet the highest quality 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 Performance Qualification (PPQ) reports, and Change Control records.
- Negotiate and prepare Quality Agreements with CMOs and ensure they work in accordance with Daiichi Sankyo's Quality Agreements.
- 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 from CMOs to global stakeholders.
- Support global and regional Quality Assurance functions, including regulatory requests and import licenses.
Requirements
To be successful in this role, you will need:
- Strong knowledge of quality management systems and regulations, including GMP and GDP.
- Excellent communication and negotiation skills.
- Ability to work independently and as part of a global team.
- Strong analytical and problem-solving skills.
- Proficiency in Microsoft Office and other relevant software.
What We Offer
At Daiichi Sankyo Europe, we offer a dynamic and inclusive work environment, with opportunities for growth and development. We are committed to fostering a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity.
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