Global Operational Quality Lead

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

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