Lead Specialist, (QA)

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

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.

What you will do

• 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.

What we are looking for

• 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

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.