Global Operational Quality Specialist

United States, Greenwood (South Carolina)

The Global Operational Quality Specialist coordinates and drives the consistent execution of Operational Quality Assurance/Quality Control (QA/QC) processes across the global network. The role ensures effective implementation of quality governance, standards, performance monitoring, training, and quality systems through cross-functional collaboration with global and site quality teams.

The function supports harmonization of QA/QC practices, coordinates global quality initiatives, monitors execution, and drives timely follow-up of quality actions, risks, and improvement opportunities. The position also facilitates knowledge sharing, strengthens inspection readiness, and promotes sustainable operational quality performance across sites.

What You Will Do

• Define and maintain the global Quality governance model, including governance structures, KPI/KQI frameworks, reporting processes, and inspection-ready performance management.
• Coordinate global escalation processes, oversee CAPA governance and effectiveness, and drive follow-up of cross-site quality risks, critical quality events, and operational QA/QC issues.
• Define, monitor, and coordinate execution of the Global Quality Plan, Annual Product Reviews, Management Reviews, and strategic quality initiatives aligned with business priorities.
• Develop and drive global Quality Culture and Quality Excellence programs, including communication, best practice sharing, and execution governance across all sites.
• Develop, implement, and continuously improve global QA/QC standards, corporate SOPs, product release frameworks, control strategies, and quality oversight models.
• Drive global harmonization of quality practices through structured gap assessments, implementation follow-up, and inspection-ready quality standards across sites.
• Define, implement, and maintain the global GxP training framework, including governance, curricula, training effectiveness, and Learning Management System processes.
• Support the global coordination of critical quality events by establishing investigation principles, promoting robust root cause analysis, and defining technical expectations for CAPA effectiveness.
• Lead quality change management for global operational quality processes by initiating global changes, performing quality impact assessments, and ensuring cross-site implementation.
• Support business growth by providing QA/QC expertise for strategic initiatives, driving process optimization and digitalization, and embedding continuous improvement into operational quality practices.
  
  

What We Are Looking For

• MSc in Pharmacy, Biotechnology, (Bio-)Engineering, Life Sciences, or a related scientific or technical discipline.
• Minimum of 10 years of experience in a GMP-regulated environment, including global quality systems, operational QA/QC, quality governance, and cross-site quality initiatives.
• Strong technical expertise in GMP, QMS, LIMS, product testing and release, validation, data integrity, inspection readiness, CAPA, change management, and regulatory expectations.
• Proven ability to develop, harmonize, and implement global quality standards, governance frameworks, and operational quality processes, driving continuous improvement and operational excellence.
• Strong analytical and digital capabilities, including KPI/KQI development, trend analysis, SharePoint, and digital reporting dashboards and automation tools to support data-driven decision-making.
• Excellent coordination, stakeholder management, and communication skills, with the ability to influence across global QA, QC, Operations, Validation, and senior leadership while delivering practical, scalable, and sustainable quality solutions
• Willingness to travel (up to 10%)
  
  

Reference: R78693

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