Senior Manager, Quality Assurance

1 week geleden


Amsterdam, Noord-Holland, Nederland Santen Voltijd
Job Description

*Please note that this role is only open to candidates located in the Netherlands*

Job Overview

Santen is seeking a highly skilled and experienced Quality Assurance professional to lead our EMEA Quality Governance team. As Senior Manager, Quality Assurance, you will be responsible for developing and implementing a robust quality management system that ensures compliance with EU pharma, distribution, and medical devices regulations.

Key Responsibilities

  • Develop and implement a comprehensive quality management system that ensures compliance with EU regulations
  • Lead the EMEA Quality Audit Management team and roll out a consolidated supplier risk assessment and audit plan
  • Deploy a new risk management process across EMEA QA functions and optimize the risk register
  • Design a GxP training matrix for quality systems under your responsibility
  • Support quality operational tasks and cross-functional projects related to EMEA Quality Management System

Requirements

  • 5+ years of experience in the pharmaceutical, medical device industry, or related area
  • Experience with e-QMS tools such as Veeva and Trackwise
  • Excellent organizational, communication, and analytical skills
  • Fluent English written and spoken

Qualifications

  • BSc or M.Sc in chemistry, pharmaceutical, biotechnology, or life science area
  • GxP experience and quality management system knowledge

Additional Information

Santen SA, the Netherlands Branch has an exclusive arrangement for recruitment services. External recruiting agencies are kindly requested not to contact us regarding the positions listed here.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.



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