Global Quality Operations Lead

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

Job summary

Lonza is seeking a Global Operational Quality Specialist to drive and harmonize QA/QC governance and standards across the global network. You will lead CAPA governance, escalation processes, and cross-site risk mitigation to ensure GMP-compliant operations across sites.

The role focuses on establishing a robust Global Quality Plan, training frameworks, and ongoing continuous improvement, enabling sustainable quality performance and inspection readiness across the network.

Qualifications

• MSc in Pharmacy, Biotechnology, Life Sciences, or related field; at least 10 years GMP-regulated experience.
• Experience developing and harmonizing global quality standards and governance.

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 events.
• Define, monitor, and coordinate execution of the Global Quality Plan and Management Reviews aligned with business priorities.
• Develop and drive global Quality Culture and Quality Excellence programs across sites.
• Develop and implement global QA/QC standards, SOPs, release frameworks, control strategies, and oversight models.
• Lead global harmonization of quality practices through gap assessments and inspection-ready standards.
• Define and maintain the global GxP training framework including governance, curricula, and LMS processes.
• Support global coordination of critical quality events with robust root-cause analysis and CAPA effectiveness.
• Lead quality change management for global processes with cross-site implementation.
• Support growth by providing QA/QC expertise for strategic initiatives and process digitalization.

Skills

GMP knowledge

Quality governance

CAPA governance

Trend analysis

Stakeholder management

Cross-site collaboration

Data analytics

Digital dashboards

Change management

GxP training framework

Education

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

Tools

SharePoint

LIMS

Job description

Lonza is seeking a Global Operational Quality Specialist to drive and harmonize QA/QC governance and standards across the global network. You will lead CAPA governance, escalation processes, and cross-site risk mitigation to ensure GMP-compliant operations across sites.

The role focuses on establishing a robust Global Quality Plan, training frameworks, and ongoing continuous improvement, enabling sustainable quality performance and inspection readiness across the network.