Global Supplier Quality Auditor

Lonza; United States; Remote; Confidential; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Competitive compensation

Job summary

Lonza in San Jose, Costa Rica, is seeking a Supplier Quality Professional to strengthen supplier quality and regulatory compliance within a global network. You will influence quality risk management, support inspection readiness, and help ensure uninterrupted supply of materials for life-changing therapies.

The role involves audits, CAPA guidance, and continuous improvement initiatives across supplier quality processes, with collaboration across sites and global leadership.

Qualifications

• Experience in Supplier Quality, Auditing, or GMP-regulated environment in life sciences.
• Strong understanding of GMP, Quality Risk Management (QRM), supplier qualification and compliance.
• Degree or equivalent qualification in a scientific, engineering, pharmaceutical, or related field.

Responsibilities

• Conduct remote, questionnaire-based supplier quality assessments and audits evaluating supplier compliance, quality systems, capabilities, and performance against GMP and regulatory requirements.
• Act as the SPOC for assigned suppliers, coordinating assessment activities and maintaining communication with suppliers, sites, and Global Quality Compliance stakeholders.
• Analyze supplier responses, supporting documentation, complaints, deviations, change notifications, and performance trends to identify compliance risks and opportunities for improvement.
• Review and assess CAPA plans, guiding suppliers and sites to ensure effective remediation and long-term compliance.
• Support global internal questionnaire-based assessments, communicating findings and compliance risks to site and global quality leadership.
• Contribute to regulatory inspection readiness activities through pre-inspection questionnaires, compliance gap assessments, and remediation support.
• Lead or participate in continuous improvement initiatives focused on questionnaire-based audit methodologies, digital assessment tools, risk management processes, and auditor training.

Job description

Lonza in San Jose, Costa Rica, is seeking a Supplier Quality Professional to strengthen supplier quality and regulatory compliance within a global network. You will influence quality risk management, support inspection readiness, and help ensure uninterrupted supply of materials for life-changing therapies.

The role involves audits, CAPA guidance, and continuous improvement initiatives across supplier quality processes, with collaboration across sites and global leadership.