Senior / Quality Operations Specialist

Consortium for Clinical Research and Innovation, Singapore; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

The Consortium for Clinical Research and Innovation, Singapore (CRIS) invites applications for a Lead QA SME to oversee GMP/CTGTP operations at ACTRIS. You will lead quality oversight, perform material release, batch review, and support qualification activities.

The role requires a Diploma or Degree in Biomedical Science or related field and 3–5 years in CTGTP/pharma. You will collaborate across Manufacturing, QC and other teams to ensure data integrity and regulatory compliance; a strong

Qualifications

• Must have QA oversight experience in GMP/CTGTP environments.
• Experience with material release, batch review and CAPA processes.
• Strong communication and regulatory-compliance mindset.

Responsibilities

• Lead and provide quality oversight for GMP/CTGTP operations.
• Serve as QA SME for cross-functional projects.
• Perform material release, batch record review, and disposition.
• Support facility and equipment qualification activities.
• Review and approve material specs, SOPs, protocols, reports, deviations.
• Support audits, inspections, risk assessments, and continuous improvement.
• Collaborate with Manufacturing, QC and other teams for compliance.

Skills

QA SME

GMP/CTGTP knowledge

Documentation

Cross-functional collaboration

Risk-based decision making

Education

Diploma or Degree in Biomedical Science/Life Sciences

Job description

Overview

The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together seven national R&D, clinical translation and service programmes to advance clinical research and innovation for Singapore, and establish important capabilities for a future-ready healthcare system.

Business Entities under CRIS include:

• Singapore Clinical Research Institute (SCRI)
• National Health Innovation Centre (NHIC)
• Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)
• Precision Health Research, Singapore (PRECISE)
• Singapore Translational Cancer Consortium (STCC)
• Cardiovascular Disease National Collaborative Enterprise (CADENCE)
• SIngapore Medical FOundation AI model (SIMFONI)

Together, CRIS makes a positive difference to Singapore patients and researchers by ensuring that these clinical research platforms and programmes are at the cutting edge of capability development and innovation. If you are as passionate as we are in clinical trials and research, we want you!

ACTRIS

The Advanced Cell Therapy and Research Institute, Singapore (ACTRIS) was established to meet the increasing clinical demand of using cellular therapeutics to treat various life‑threatening diseases. ACTRIS’ vision is to be the national and regional Centre of Excellence for discovery, process development and manufacturing of cellular‑based therapeutics across the broad spectrum of immunotherapy and regenerative medicine, encompassing both investigational and approval products for the local market. We also provide value‑added services such as workforce training, regulatory facilitation and ancillary material standardization, pertaining to delivery of cellular therapy to patients.

RESPONSIBILITIES

• Lead and provide quality oversight for GMP/CTGTP operations and serve as QA SME for cross‑functional projects.
• Perform material release, batch record review, and batch disposition.
• Support facility and equipment qualification activities, including tag‑in/tag‑out processes.
• Review and approve material specifications, SOPs, protocols, reports, deviations, CAPAs, and change controls.
• Support audits, inspections, quality risk assessments, and continuous improvement initiatives.
• Collaborate with Manufacturing, QC, and other functional teams to ensure compliance, data integrity and operational excellence.
• Perform other duties as assigned by Reporting Officer.

EDUCATION & EXPERIENCE

• Diploma or Degree in Biomedical Science, Life Sciences, or a related discipline.
• 3–5 years of relevant experience in CTGTP, pharmaceuticals, biologics, or other GMP‑regulated environment.
• Strong understanding of GMP and HSA CTGTP requirements.
• Proven experience in quality operations, deviation investigation, and change control management.
• Experience in qualification and validation activities is an advantage.

SKILLS

• Strong written, verbal, and interpersonal communication skills.
• Highly organised, meticulous, and detail‑oriented.
• Able to work independently and collaboratively within a diverse, multi‑cultural environment.
• Good problem‑solving and risk‑based decision‑making skills.

What you need to know

Successful candidate will be offered a 3-year contract, renewable. We regret that only shortlisted candidates will be contacted. For more information about CRIS and the Business Entities, visit our websites below:

• CRIS – https://www.cris.sg
• SCRI – https://www.scri.edu.sg
• NHIC – https://www.nhic.sg
• ACTRIS – https://www.actris.sg
• PRECISE – https://www.npm.sg
• STCC – https://www.stcc.sg
• CADENCE – https://www.cris.sg/our-programmes/cadence/