Global Operational Quality Specialist

Lonza; Greenwood (SC); On-site; Confidential; Full time

Job summary

Lonza in Greenwood, SC is seeking a Global Operational Quality Specialist to coordinate QA/QC across the global network and harmonize quality practices. You will drive governance, training, and continuous improvement while ensuring compliance with GMP and regulatory expectations.

Key focus areas include establishing global quality plans, CAPA governance, KPI development, data-driven reporting, and cross-site collaboration with senior leadership to sustain sustainable operational quality

Qualifications

• MSc in Pharmacy, Biotechnology, or Life Sciences or related discipline.
• Minimum of 10 years in GMP-regulated environment with global quality systems.
• 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 and harmonize global quality standards and governance frameworks.
• Excellent coordination, stakeholder management, and communication across senior leadership.

Responsibilities

• Define and maintain the global Quality governance model, including KPI/KQI frameworks and inspection-ready performance management.
• Coordinate global escalation processes, oversee CAPA governance and effectiveness, and drive follow-up of cross-site quality risks and issues.
• Define, monitor, and coordinate execution of the Global Quality Plan, Annual Product Reviews, and Management Reviews.
• Develop and drive global Quality Culture and Quality Excellence programs across sites.
• Develop, implement, and continuously improve global QA/QC standards, SOPs, product release frameworks, and control strategies.
• Drive global harmonization of quality practices with gap assessments and inspection-ready standards.
• Define, implement, and maintain the global GxP training framework and LMS processes.
• Support global coordination of critical quality events with robust root cause analysis and CAPA expectations.
• Lead quality change management for global operational processes and cross-site implementation.
• Support business growth by providing QA/QC expertise for strategic initiatives and process digitalization.

Skills

Coordination

Stakeholder management

Communication

Data analysis

Education

MSc in Life Sciences

Tools

SharePoint

Learning Management System

Digital dashboards

Job description

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