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.
Requirements
Degree in Science, Engineering, Biotechnology, Pharmaceutical Sciences, Life Sciences, or a related discipline.
Experience in Quality Assurance within a GMP-regulated pharmaceutical, biotechnology, cell therapy, biologics, or contract manufacturing environment.
Strong knowledge of cGMP requirements, quality systems, validation, technical compliance, deviation management, CAPA, change control, and regulatory expectations.
Experience supporting regulatory inspections, customer audits, supplier audits, and quality management system activities.
Demonstrated ability to lead complex investigations, assess quality risks, make sound quality decisions, and drive issue resolution across cross-functional teams.
Strong communication, stakeholder management, project leadership, and coaching skills with the ability to influence decisions at multiple organizational levels.
Experience with electronic Quality Management Systems (eQMS), TrackWise, data integrity principles, and GMP documentation management is preferred.
About Lonza
Ready to shape the future of life sciences?
Additional Information
Location: Tuas, Singapore
Be part of Lonza's Quality Assurance team, where you will play a key role in ensuring compliance, quality oversight, and continuous improvement across a multi-product cGxP contract manufacturing facility. As a Lead Specialist, QA, you will provide technical leadership and quality guidance across Quality Systems, Validation & Technical Compliance, Quality Compliance, Quality Operations, or Customer Projects. This role requires strong quality expertise, sound decision-making, and the ability to lead complex investigations, support audits and inspections, and drive cross-functional quality initiatives that ensure product quality, patient safety, and regulatory compliance.
What you will get
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- Opportunities to collaborate with global cross-functional teams.
- Ongoing learning and professional development opportunities.
- Our full list of global benefits can be found here: Lonza Benefits .
Lonza · Sg - Tuas, Singapore