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Head, Quality
3 months ago
Job Title:
Head, Quality**
Business Entity: Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)
Overview
The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together six
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.
The 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)
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.
What you will be working on
**(A) GENERAL
**The Head of Quality must possess extensive biologics, cell culture and/or pharmaceutical quality
operations leadership experience. The incumbent provides leadership for all Quality related
activities across the business including operation of Quality Control (QC) laboratory and Quality
Assurance (QA) oversight on manufacturing processes, quality events (Deviation/Investigation,
CAPA, Change Control Management, Complain and Recall), Validation, Quality Systems (including
IT capabilities), Inspection and Audit Management, Project Support and other functional areas if
deem related.
- Deploy the best practice quality vision and GMP regulatory compliance strategy to meet business
- Develop, lead and manage the Quality Management Systems (QMS), implement new or identify
- Build and maintain expertise within department; ensure ongoing development and training
- Report the performance of the Quality performance indicators to Senior Management
- Manage the Quality budgets.
- Partner with customers on Quality strategy and QMS execution.
- Support the development and harmonization of quality standards and processes across various
- Ensure that quality team maintains appropriate independence and there is no conflict of interest
o Regulatory requirements and day-to-day operational priorities
- Quality activities from the production activities for the product batch release.
- Share the responsibility with various stack holder (i.e. production, logistic team) to ensure
- Interface and communicate with Process Development, Production and Business
- Ensure control (approval/rejection) of raw materials, starting materials, equipment that are used in
- Ensure the inspection, investigation and taking of samples is appropriate in order to monitor
- Ensure all necessary testing is carried out and associate records are evaluated in a timely and
- Ensure that QC operations are carried out using appropriate equipment and premises are
- Ensure of conditions for outsourced activities.
- Ensure Quality review and approval/rejection of all GMP related procedures, documents and
- Advise or assist in continuous improvement activities throughout the manufacturing cycles to ensure
- Ensure risk management principles, the essence of ICHQ9 and a continuous improvement
- Ensure that all investigation, deviation actions, critical documentation and