Head of Business Quality - EMEA (m/f)
On-siteKomorniki, Greater Poland, Poland
Job Summary
Implement global quality strategy and develop region-specific plans to ensure regulatory compliance and operational performance across EMEA. Oversee the Quality Management System, internal audit programs, and external regulatory inspections while managing change controls, CAPAs, and nonconformance investigations. Provide quality leadership for manufacturing operations, including NPI and production transfers, and support root cause analysis for operational issues. Lead and develop a high-performing regional quality organization of 30+ team members across 15+ countries, fostering a strong quality culture and driving continuous improvement initiatives.
Required Qualifications
- 15+ years of experience in Quality Assurance and/or Regulatory Affairs within the medical device or pharmaceutical industry
- Strong experience with Quality Management Systems (e.g., ISO 13485, FDA 21 CFR Part 820, EU MDR) and regulatory compliance
- Experience supporting manufacturing operations, product lifecycle quality, and customer quality processes
- Proven leadership experience managing international teams across multiple sites and cultures
- Experience with QMS implementation, remediation activities, and regulatory gap assessments
- Demonstrated ability to manage complex operations and drive continuous improvement initiatives
- Strategic mindset with strong leadership and decision-making capabilities
- Strong communication and stakeholder management skills, with the ability to influence across functions and leadership levels
- Analytical thinker with the ability to translate quality data into actionable insights
- Ability to operate effectively in a fast-paced, global environment with evolving priorities
- Committed to quality excellence, compliance, and continuous improvement
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