CGT QA & Compliance Lead - Product Release

Lonza; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A global leader in life sciences is seeking a Specialist, QA (CGT) in Singapore. This role supports Quality Assurance activities in a cGMP environment, ensuring timely release of products. Candidates should have a degree in Science or Engineering and significant experience in Quality Assurance within a cGMP manufacturing setting. This position offers a dynamic and inclusive work culture along with comprehensive benefits.

Benefits

Agile career and dynamic working culture

Inclusive and ethical workplace

Daily company bus to site

Fully paid medical insurance with family options

Access to global benefits portfolio

Qualifications

• Experience in Quality Assurance within a cGMP manufacturing environment, ideally in Cell and Gene Therapy (CGT) or biopharmaceuticals.
• Strong knowledge of cGMP, GDocP, and applicable regulatory requirements.
• Proven ability to lead investigations, change controls, and cross-functional projects.

Responsibilities

• Review executed batch records to ensure compliance with cGMP.
• Compile lot genealogy and disposition packages to drive timely product release.
• Provide QA oversight for product status and shipping documents.
• Support and approve deviation investigations and CAPA implementation.
• Oversee changes to operational documents like MBRs and SOPs.
• Participate in QA shopfloor activities and audits.
• Lead and coordinate site projects and change controls.

Skills

Quality Assurance Experience

Knowledge of cGMP and GDocP

Batch Record Review

Deviation Management

CAPA Implementation

Stakeholder Management

Education

Degree or Diploma in Science or Engineering

Job description

A global leader in life sciences is seeking a Specialist, QA (CGT) in Singapore. This role supports Quality Assurance activities in a cGMP environment, ensuring timely release of products. Candidates should have a degree in Science or Engineering and significant experience in Quality Assurance within a cGMP manufacturing setting. This position offers a dynamic and inclusive work culture along with comprehensive benefits.