Quality & Compliance Lead

About the role

The Quality & Compliance Lead will drive quality and regulatory compliance across global service sites, ensuring adherence to FDA, ISO and internal 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 other global regulatory requirements.
• Lead the implementation and consistency of the Quality Management System (QMS) across sites.
• Manage resolution of non‑conformances, CAPAs and audit findings.
• Support internal and external audits and maintain audit readiness.
• Monitor, analyze 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.
• Proven experience in quality assurance, compliance and service operations.
• Expertise in risk management and process improvement (Lean/Six Sigma preferred).
• Excellent stakeholder management and cross‑functional collaboration skills.
• Ability to travel to service sites and potential to lead small teams.
• Commitment to Health, Safety & Environmental (HSE) standards and company policies.

Required skills

• QMS implementation and maintenance
• FDA regulatory compliance
• ISO standards (e.g., ISO 9001)
• CAPA management
• Audit preparation and execution
• Lean methodology
• Six Sigma principles
• Risk management