Senior QA Leader – Cell & Gene Therapy

ESCO ASTER PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Esco Aster Pte Ltd, part of Esco Lifesciences Group, is seeking a QA professional to support GMP readiness and ongoing compliance for cell and gene therapy manufacturing in a cGMP environment. You will oversee deviations, CAPA, change controls, and document reviews on the manufacturing floor in Singapore.

The role requires 3-5 years GMP QA experience, knowledge of ICH Q7/Q9, GDP, regulatory standards, and proficiency with eQMS and electronic documentation.

Qualifications

• Bachelor's or Master’s in Life Sciences, Biotechnology, Pharmacy or equivalent.
• 3–5 years of GMP QA/Quality experience, preferably in Cell & Gene Therapy or ATMP manufacturing.
• Experience in cell and gene therapy manufacturing is an added advantage.
• Strong knowledge of cGMP, GDP, FDA/EMA standards, PIC/S, ICH Q7/Q9, Annex 1, and data integrity.
• Proficiency with quality systems (deviation, CAPA, change control, document control, batch release).
• Familiar with eQMS and electronic document systems.
• Excellent communication, analytical, problem-solving, and collaborative skills.
• Able to work independently and mentor others; strong on QA shop-floor oversight.
• Proficient in MS Office Suite (Word, Excel).

Responsibilities

• Initiate, investigate, and close deviations, and manage CAPA processes including effectiveness checks.
• Review, assess, and manage change controls related to materials, equipment, processes, and documentation.
• Perform thorough review of batch manufacturing records, logbooks, and associated documentation.
• Provide real-time QA support on the manufacturing floor during production and aseptic operations.
• Review, revise, and approve GMP documentation including SOPs, MBRs, and work instructions.
• Conduct gap assessments of processes and procedures against GMP/regulatory expectations.
• Support internal and external audits including preparation, hosting, and response drafting.
• Participate in continuous improvement initiatives and cross-functional project teams.
• Collaborate with manufacturing, QC, validation, and engineering to ensure timely quality deliverables.
• Support inspection readiness activities and promote a culture of quality.
• Train and mentor operations staff on quality procedures as needed.
• Utilize eQMS to manage workflows and records.
• Assist Quality Control with data trending and investigations.

Skills

GMP QA experience

Quality systems

Change control

Documentation review

Cross-functional collaboration

MS Office

Education

Bachelor's in Life Sciences

Master's in Life Sciences

Tools

eQMS

Job description

Esco Aster Pte Ltd, part of Esco Lifesciences Group, is seeking a QA professional to support GMP readiness and ongoing compliance for cell and gene therapy manufacturing in a cGMP environment. You will oversee deviations, CAPA, change controls, and document reviews on the manufacturing floor in Singapore.

The role requires 3-5 years GMP QA experience, knowledge of ICH Q7/Q9, GDP, regulatory standards, and proficiency with eQMS and electronic documentation.