Senior Quality Manager CMO

vor 4 Wochen

Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit
Senior Quality Manager CMO Job Description

At Daiichi Sankyo Europe, we are committed to delivering high-quality products that meet the needs of our patients. We are seeking a highly skilled Senior Quality Manager CMO to join our team.

Key Responsibilities:
  • Manage quality oversight at Contract Manufacturing Organizations (CMOs) to ensure compliance with regulatory requirements and company standards.
  • Develop and implement effective quality management systems to prevent and correct deviations and complaints related to manufacturing.
  • Collaborate with CMOs to define and implement corrective and preventive actions (CAPAs) to address quality issues.
  • Review and evaluate quality-related documents, such as APQRs, PPQ reports, and CPVs, to ensure compliance with regulatory requirements.
  • Prepare and negotiate Quality Assurance Agreements (QAAs) with CMOs to ensure they meet our quality standards.
  • Support CMOs during Authority Inspections and perform audits on behalf of Daiichi Sankyo Europe to ensure compliance with regulatory requirements.
  • Identify and escalate quality risks at CMOs to ensure timely resolution.
Requirements:
  • Proven experience in quality management, preferably in a pharmaceutical or biotechnology industry.
  • Strong knowledge of regulatory requirements, such as GMP and ISO 9001.
  • Excellent communication and collaboration skills to work effectively with CMOs and internal stakeholders.
  • Ability to analyze complex quality issues and develop effective solutions.
  • Fluency in English, both written and spoken.
Why Work with Us?

At Daiichi Sankyo Europe, we offer a dynamic and collaborative work environment that fosters innovation and growth. We are committed to making a difference in the lives of our patients and are seeking talented individuals who share our passion for quality and excellence. If you are a motivated and experienced quality professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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