Global Quality & Compliance Leader

Lonza Group; Greenwood (SC); On-site; USD 110,000 - 160,000; Full time

Job summary

Lonza Group in Greenwood, SC, seeks a Global Operational Quality Specialist to coordinate QA/QC across the global network, defining governance models, implementing KPI frameworks, and driving inspection readiness and continuous improvement across sites.

The role requires a MSc in a related field and 10+ years in GMP environments, with strong expertise in GMP, QMS, LIMS, CAPA, change management, data integrity, and regulatory expectations.

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, 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

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

GMP

QMS

LIMS

Product testing & release

Validation

Data integrity

CAPA & change management

Regulatory expectations

KPI/KQI analytics

Stakeholder coordination

Digital reporting & automation

Education

MSc in Pharmacy, Biotechnology, Life Sciences, or related

Tools

SharePoint

LIMS software

Digital dashboards

Job description

Lonza Group in Greenwood, SC, seeks a Global Operational Quality Specialist to coordinate QA/QC across the global network, defining governance models, implementing KPI frameworks, and driving inspection readiness and continuous improvement across sites.

The role requires a MSc in a related field and 10+ years in GMP environments, with strong expertise in GMP, QMS, LIMS, CAPA, change management, data integrity, and regulatory expectations.