Global Quality Governance Lead

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

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.