Head, Quality - Singapore - Consortium for Clinical Research and Innovation Singapore

Consortium for Clinical Research and Innovation Singapore
Consortium for Clinical Research and Innovation Singapore
Verified Company
Singapore

1 week ago

Wei Jie

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Wei Jie

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Description

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)
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.


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
strategic objectives and operational needs.

  • Develop, lead and manage the Quality Management Systems (QMS), implement new or identify
potential improvement in system, where appropriate.

  • Build and maintain expertise within department; ensure ongoing development and training
opportunity is provided for the staff to allow the team to support site operations effectively.

  • Report the performance of the Quality performance indicators to Senior Management
Committee for necessary review and improvements.

  • 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
procedures conducted at the GMP facility.

  • Ensure that quality team maintains appropriate independence and there is no conflict of interest
between
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
production and storage is done in accordance with the relevant specification or instruction.

  • Interface and communicate with Process Development, Production and Business
Development to ensure that production batches are reviewed and released in a timely manner.

  • Ensure control (approval/rejection) of raw materials, starting materials, equipment that are used in
combined CTGTP, packaging materials, intermediate, bulk and finished product.

  • Ensure the inspection, investigation and taking of samples is appropriate in order to monitor
factors which may affect product quality.

  • Ensure all necessary testing is carried out and associate records are evaluated in a timely and
compliant manner.

  • Ensure that QC operations are carried out using appropriate equipment and premises are
maintained under suitable conditions.

  • Ensure of conditions for outsourced activities.
  • Ensure Quality review and approval/rejection of all GMP related procedures, documents and
records. Enforcement of investigations for non-conformance issues.

  • Advise or assist in continuous improvement activities throughout the manufacturing cycles to ensure
all quality requirements are met.

  • Ensure risk management principles, the essence of ICHQ9 and a continuous improvement
culture are built into organization.

  • Ensure that all investigation, deviation actions, critical documentation and
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