• Provide Quality Assurance oversight for manufacturing, laboratory, validation, technical compliance, quality systems, and customer project activities, ensuring compliance with cGMP requirements and Lonza quality standards.
• Lead and support complex quality events including deviations, CAPAs, change controls, customer complaints, investigations, and risk assessments using structured root cause analysis methodologies.
• Review and approve quality documentation including SOPs, protocols, reports, batch records, validation documents, TrackWise records, and other GMP documentation to ensure accuracy and compliance.
• Support and represent QA during regulatory inspections, customer audits, and supplier audits, acting as a subject matter expert and ensuring inspection readiness at all times.
• Drive cross-functional quality improvement initiatives, technical projects, and operational excellence programs while providing guidance and mentorship to junior team members.
• Provide quality oversight for product disposition, manufacturing operations, validation activities, customer projects, and quality system processes, ensuring timely execution and risk-based decision making.
• Promote a strong culture of quality, data integrity, compliance, and continuous improvement while building effective relationships with internal and external stakeholders.