EMEA Regional Quality Integration Leader
Core
Leading and coordinating quality integration activities across EMEA regions to ensure adherence to regulatory requirements and internal quality standards following mergers, acquisitions, or significant process changes.
Role type
Senior regional quality integration leader
Builds
Harmonized quality management systems (QMS), processes, and procedures across newly acquired entities or major business changes within the EMEA region
Domain
Medical device / Pharmaceutical industry
Required skills
Quality Assurance leadership, Quality system integration (M&A), Regulatory compliance (ISO 13485, MDR, IVDR), Gap analysis, Change management, Cross-functional team guidance, Risk mitigation, Due diligence support, Continuous improvement, Mentorship
Preferred skills
Master's degree, Fluency in German or French, Extensive travel readiness
Technologies
CAPA, FMEA, Lean manufacturing
Responsibilities
Develop regional quality integration strategies, Guide cross-functional teams through QMS integration, Conduct gap analyses and implement remediation plans, Harmonize quality documentation and training, Act as primary contact for quality integration, Monitor integration progress and mitigate risks, Participate in quality-focused due diligence, Provide expert mentorship to regional teams
Seniority
Senior, hands-on IC with management responsibilities