QA Lead, Compliance & Quality Improvement

Lonza Group Ltd.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Performance recognition

Global collaboration

Professional development

Job summary

Lonza Group Ltd. in Tuas, Singapore, is seeking a Lead Specialist, QA to provide technical leadership across Quality Systems, Validation, Technical Compliance, and Quality Operations.

You will guide investigations, support audits and inspections, and drive cross-functional quality initiatives to ensure product quality and regulatory compliance. This role requires strong quality expertise, decisive decision-making, and the ability to mentor junior staff while promoting data integrity, risk-based

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality Assurance

GMP knowledge

Deviation management

CAPA

Change control

Audit support

Root cause analysis

Leadership

Regulatory compliance

Education

Bachelor's degree in Science or Engineering

Tools

eQMS

TrackWise

Job description

Lonza Group Ltd. in Tuas, Singapore, is seeking a Lead Specialist, QA to provide technical leadership across Quality Systems, Validation, Technical Compliance, and Quality Operations.

You will guide investigations, support audits and inspections, and drive cross-functional quality initiatives to ensure product quality and regulatory compliance. This role requires strong quality expertise, decisive decision-making, and the ability to mentor junior staff while promoting data integrity, risk-based