Quality & Compliance Lead

About the role

The Quality & Compliance Lead will drive quality and regulatory compliance across global service sites. This role ensures adherence to FDA, ISO and other standards while supporting transformation and service initiatives.

Key responsibilities

• Act as the primary Quality & Compliance subject‑matter expert for service projects, transfers and cost‑improvement initiatives.
• Ensure compliance with FDA, ISO and global regulatory requirements.
• Lead the implementation and consistency of the Quality Management System (QMS) across all service locations.
• Manage resolution of non‑conformances, CAPAs and audit findings.
• Support internal and external audits and maintain audit readiness.
• Monitor, analyse and report KPIs, quality metrics and service performance.
• Partner with Service Operations, Supply Chain and Customer Quality teams to harmonise processes and drive continuous improvement.
• Deliver training on quality processes, system updates and procedural changes.
• Conduct data‑driven analysis to improve compliance and operational performance.
• Communicate risks, issues and improvement opportunities to leadership.

Required profile

• Strong knowledge of QMS, FDA regulations, ISO standards, CAPA and audit processes.
• Experience in quality assurance, compliance and service operations.
• Expertise in risk management and process improvement, preferably Lean or Six Sigma.
• Proven ability to manage stakeholders and work cross‑functionally.
• Excellent analytical, communication and training capabilities.

Required skills

• QMS
• FDA regulations
• ISO standards
• CAPA
• Lean methodology
• Six Sigma