Quality And Compliance Manager

Thermo Fisher Scientific

Breda, Netherlands
On-site
Maintain regulatory compliance
Drive continuous improvement of quality systems
Investigate quality issues
Thermo Fisher Scientific is seeking a Quality and Compliance Manager to ensure regulatory compliance and enhance quality systems across its operations in Europe. The role requires collaboration with various teams to address quality issues and implement improvements, with a strong emphasis on experience in regulated industries

Job Summary

  • As a Quality and Compliance Manager, you will maintain regulatory compliance and drive continuous improvement of quality systems to support our mission of enabling customers to make the world healthier, cleaner and safer.
  • This role involves collaborating with cross-functional teams, working closely with the Senior Quality Manager, the IES (Instrument & Enterprise Services) EMEA Quality Team and regional management teams and the global quality organisation to investigate quality issues, conduct audits, supplier oversight, manage nonconformities, complaints, deviations, training and implement corrective actions.
  • At Thermo Fisher Scientific, we are committed to fostering a diverse and inclusive workplace. We offer competitive compensation, excellent benefits, and opportunities for professional growth.

Matching Summary

Match Score: 85

Thermo Fisher Scientific is seeking a Quality and Compliance Manager to ensure regulatory compliance and enhance quality systems across its operations in Europe. The role requires collaboration with various teams to address quality issues and implement improvements, with a strong emphasis on experience in regulated industries.

Skills & Requirements

Must-have

  • Maintain regulatory compliance
  • Drive continuous improvement of quality systems
  • Investigate quality issues
  • Conduct audits
  • Supplier oversight
  • Manage nonconformities and deviations
  • Implement corrective actions
  • Develop and maintain data infrastructure
  • Manage document control
  • Support quality management needs
  • Root cause analysis
  • Statistical analysis and data trending

Nice-to-have

  • Foster a culture of quality excellence
  • Collaborate across functions and levels
  • Customer-centric approach
  • Work independently
  • Risk assessment methodologies
  • Continuous improvement tools

Key Requirements

  • Advanced Degree plus 3 years of experience or Bachelor's Degree plus 5 years of experience in quality assurance/quality control
  • Minimum 3 years proven experience with IQ, OQ, PQ
  • Strong knowledge of EU or USA GMP and GLP regulations
  • ISO 9001/13485/17025 standards
  • Experience with quality management systems, CAPA, deviation management, change control
  • Trained as internal auditor or extensive auditing experience
  • Experience conducting and hosting internal/external audits
  • Proficiency in English, fluency in Dutch and/or German preferred
  • Proficiency with quality systems software and Microsoft Office applications

Work Rights

Not specified

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