Lead Specialist, Quality Assurance (QA)

About the role

Lonza is hiring a Lead Specialist, QA for its Quality Assurance team at its multi-product cGxP contract manufacturing facility in Tuas, Singapore. You will provide technical leadership and quality guidance across Quality Systems, Validation & Technical Compliance, Quality Compliance, Quality Operations or Customer Projects, leading complex investigations, supporting audits and inspections and driving cross-functional quality initiatives.

Key responsibilities

• Provide QA 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 such as deviations, CAPAs, change controls, customer complaints, investigations and risk assessments using structured root cause analysis.
• Review and approve quality documentation including SOPs, protocols, reports, batch records, validation documents and TrackWise records.
• Support and represent QA during regulatory, customer and supplier audits, acting as a subject matter expert and keeping inspection readiness.
• Drive cross-functional quality improvement initiatives and mentor junior team members.
• Oversee product disposition, manufacturing operations, validation activities and quality system processes with risk-based decision making.
• Promote a culture of quality, data integrity and continuous improvement and build relationships with internal and external stakeholders.

Required profile

• Degree in Science, Engineering, Biotechnology, Pharmaceutical Sciences, Life Sciences or a related discipline.
• Experience in QA within a GMP-regulated pharmaceutical, biotechnology, cell therapy, biologics or contract manufacturing environment.
• Experience supporting regulatory, customer and supplier audits and quality management system activities.
• Ability to lead complex investigations, assess quality risks and make sound quality decisions.

Required skills

• Strong knowledge of cGMP, quality systems, validation, technical compliance, deviation management, CAPA, change control and regulatory expectations.
• Preferred: experience with electronic Quality Management Systems (eQMS), TrackWise, data integrity principles and GMP documentation management.

What we offer

• An agile career and dynamic working culture in an inclusive, ethical workplace.
• Compensation programs that recognise high performance.
• Collaboration with global cross-functional teams and ongoing learning and professional development.
• Full list of global benefits available through Lonza.