Global Operational Quality Specialist

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

Job summary

Lonza is seeking a Global Operational Quality Specialist to lead governance and continuous improvement across the worldwide QA/QC network. You will drive KPIs, CAPA effectiveness, and inspection readiness while partnering with site quality teams.

In this role you define the global Quality Plan, ensure harmonized standards, and support strategic quality initiatives aligned with business priorities. Travel up to 10% may be required.

Qualifications

• MSc in Pharmacy, Biotechnology, (Bio-)Engineering, Life Sciences, or related field.
• 10+ years in GMP-regulated environments with global QA/QC and cross-site initiatives.
• Expertise in GMP, QMS, LIMS, product testing and release, validation, data integrity, CAPA, regulatory expectations.
• Experience developing and harmonizing global quality standards and governance.
• Strong analytical and digital capabilities: KPI/KQI development, trend analysis, SharePoint, dashboards, automation.
• Excellent coordination and communication across QA, QC, Operations, Validation, and leadership.
• Willingness to travel up to 10%

Responsibilities

• Define and maintain the global Quality governance model, including governance structures and KPI frameworks.
• Coordinate global escalation processes, CAPA governance, and cross-site quality risks.
• Define and monitor the Global Quality Plan, API Reviews, and strategic quality initiatives.
• Develop and drive global Quality Culture and Quality Excellence programs across sites.
• Develop, implement, and continuously improve global QA/QC standards, SOPs, and control strategies.
• Drive harmonization of quality practices through gap assessments and inspection readiness.
• Define, implement, and maintain the global GxP training framework and LMS processes.
• Support critical quality events with robust root cause analysis and CAPA effectiveness.
• Lead quality change management for global processes and cross-site implementation.
• Support business growth by providing QA/QC expertise for strategic initiatives and digitization.

Skills

GMP knowledge

Quality governance

Cross-site collaboration

Stakeholder management

Analytical skills

Digital reporting dashboards

Education

MSc in Pharmacy/Biotech/Engineering/Life Sciences

Tools

LIMS

SharePoint

Data visualization tools

Job description

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%)