Quality Compliance Lead

Role SummaryLead quality and compliance activities across global Service Sites, ensuring regulatory adherence, process harmonization, and successful execution of transformation and service initiatives.

Key ResponsibilitiesAct as primary Quality & Compliance SME for service projects, transfers, and cost improvement initiativesEnsure compliance with FDA, ISO, and global regulatory standardsDrive Quality System (QMS) adherence and procedural consistency across service sitesLead resolution of Nonconformances (NCs), CAPAs, and audit findingsSupport internal/external audits and ensure audit readinessMonitor and analyze KPIs, quality metrics, and service performancePartner with Service Operations, Supply Chain, and Customer Quality teamsSupport process harmonization, continuous improvement, and risk assessment activitiesDelivery training on quality processes, system updates, and procedural changesConduct data-driven analysis to improve compliance and operational performanceSupport deviation investigations and documentationCommunicate risks, issues, and improvement opportunities to leadershi
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Qualifications & SkillsStrong knowledge of QMS, FDA regulations, ISO standards, CAPA, auditsExperience in quality assurance, compliance, and service operationsExpertise in risk management and process improvement (Lean/Six Sigma preferred)Strong stakeholder management and cross-functional collaborationExcellent analytical, communication, and training skil
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Additional InformationAbility to travel to service sites as neededPotential to lead small teamsCommitment to Health, Safety & Environmental (HSE) standards and company polic
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