Senior QA Lead: GMP Manufacturing & Quality Oversight

Lonza; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Medical insurance (family option)

Transport to Tuas site

Job summary

Lonza Singapore is seeking a QA Operations professional to support manufacturing in a GMP biopharmaceutical facility at Tuas. You will coordinate batch release, review documents, and ensure compliance across quality systems.

With 1–3 years of relevant experience, you will collaborate with cross-functional teams to uphold risk management and continuous improvement, while adhering to regulatory requirements and safety standards at Lonza.

Qualifications

• Bachelor's degree in a life sciences or related field.
• 1-3 years' QA or GMP-regulated experience in biopharma.
• Experience reviewing SOPs, batch records, and deviations.
• Familiarity with quality systems and regulatory requirements.

Responsibilities

• Coordinate lot disposition and product release activities, including shipping documents.
• Review and approve SOPs, protocols, reports, batch records, and other quality documents.
• Provide quality oversight of product status and the quality tag-out system.
• Review deviation investigations and apply RCA for timely closure.
• Oversee CAPA implementation and closure.
• Provide QA guidance on manufacturing floor activities per GMP and SOPs.
• Support manufacturing changeovers and day-to-day QA in GMP facility.
• Identify cGMP/GDP non-compliance and provide corrective guidance.
• Analyze data to resolve quality issues and suggest process improvements.
• Participate in audits and follow-up activities.
• Lead Quality projects and continuous improvement initiatives.
• Provide compliance guidance to cross-functional teams.
• Build relationships with stakeholders.
• Perform other duties as assigned.

Skills

QA Operations

GMP Compliance

Cross-functional collaboration

Root Cause Analysis

Quality Management Systems

Education

Bachelor's degree in Life Sciences or related field

Tools

QMS (Quality Management System)

Job description

Lonza Singapore is seeking a QA Operations professional to support manufacturing in a GMP biopharmaceutical facility at Tuas. You will coordinate batch release, review documents, and ensure compliance across quality systems.

With 1–3 years of relevant experience, you will collaborate with cross-functional teams to uphold risk management and continuous improvement, while adhering to regulatory requirements and safety standards at Lonza.