Global Operational Quality Specialist

Lonza Biologics, Inc.; Greenwood (MS); On-site; Confidential; Full time

Job summary

Lonza Biologics, Inc. is seeking a Global Operational Quality Specialist to drive QA/QC governance and harmonize practices across its global network, ensuring strong inspection readiness and quality systems.

The role collaborates with global and site teams to implement quality standards and continuous improvement initiatives. You will coordinate CAPA governance, risk management, and quality initiatives, defining the Global Quality Plan and training frameworks while driving a culture of quality

Qualifications

• MSc in Pharmacy, Biotechnology, (Bio-)Engineering, Life Sciences, or a related scientific field.
• Minimum of 10 years in a GMP-regulated environment with global quality systems.
• Strong 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.
• Excellent analytical and digital capabilities, including KPI/KQI development, trend analysis, SharePoint, and digital reporting dashboards and automation tools.

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, 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.

Skills

Quality governance

GxP

CAPA governance

Data analytics

Cross-functional collaboration

Digital reporting dashboards

Education

MSc in Pharmacy, Biotechnology, (Bio-)Engineering, Life Sciences, or related

Tools

LIMS

SharePoint

Automation 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%)