Global Operational Quality Specialist

Lonza; Kansas; On-site; Confidential; Full time

Job summary

Lonza is seeking a Global Operational Quality Specialist to coordinate and drive QA/QC processes across a worldwide network. You will ensure governance, performance monitoring, training, and quality systems are implemented through cross-functional collaboration with global and site teams.

You will harmonize QA/QC practices, lead quality initiatives, and promote inspection readiness while driving continuous improvement and digitalization of operational quality across sites.

Qualifications

• 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 with global quality systems, QA/QC, governance, and cross-site initiatives.
• Strong technical expertise in GMP, QMS, LIMS, product testing and release, validation, data integrity, inspection readiness, CAPA, change management, and regulatory expectations.

Responsibilities

• 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 and quality events.
• Define, monitor, and coordinate execution of the Global Quality Plan, Annual Product Reviews, Management Reviews, and strategic quality initiatives.
• Develop and drive global Quality Culture and Quality Excellence programs across all sites.
• Develop, implement, and continuously improve global QA/QC standards, SOPs, release frameworks, and control strategies.
• Drive global harmonization of quality practices and inspection-ready standards across sites.
• Define and maintain the global GxP training framework, including governance, curricula, and Learning Management System processes.
• Support global coordination of critical quality events with robust root cause analysis and CAPA effectiveness.
• Lead quality change management for global operational quality processes and cross-site implementations.
• Support business growth by providing QA/QC expertise for strategic initiatives and continuous improvement.

Skills

GMP Expertise

QA/QC Leadership

Data Analytics

CAPA

GxP Compliance

Cross-functional Collaboration

Education

MSc in Pharmacy

Life Sciences/related MSc

Tools

LIMS

SharePoint

Dashboard 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%)