Quality Manager

Company Background

Tessa Therapeutics is a leading biotechnology company specializing in the research, clinical development, and commercialization of cancer immunotherapy treatments. We are a global leader in employing Virus-Specific T cells (VST) to treat cancer. We are currently conducting the world’s first US FDA-registered Phase III T cell therapy trial in NPC, or any cancer indication. We have multiple recruitment sites in the following countries: Singapore, Malaysia, Taiwan, Thailand, and the US. In addition, we have a robust pipeline of both pre-clinical and clinical treatments, targeting multiple cancer indications.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies.

We are looking for highly motivated and enthusiastic individuals who are interested to be part of our Quality team.

 

Job Position
Quality Manager/Senior Quality Executive

Reports to
Head of Quality

Job Description:

  • Managing of QA documentation and stability testing protocol
  • Follow up on change control, deviation, investigation, corrective and preventive actions
  • Provide necessary QA support to Production, Supply chain, QC and Hospital Operations, Hospital relations and their documentation
  • Assist in internal/external audit and vendor audit and review
  • Supporting of risk assessment activity
  • Responsible for product complaint handling and recall
  • Involved in data summary/trending/analysis and product batch release
  • Prepare necessary data for regulatory submission

Requirements:

  • Bachelor Degree/Diploma or higher in Biomedical Science/Biochemistry/Microbiology/ Biotechnology or any related field with at least 3 to 5years of relevant working experience
  • Preferred with good understanding of Quality in a cell therapy manufacturing environment
  • Strong knowledge of US FDA guidelines, 21 CFR Part 210 and 211 requirements, PIC/S and ICH guidelines
  • Experience in QA and laboratory testing in a GMP/GTP/GLP setup are preferred
  • Experience in handling audits from various regulatory agencies, eg. NPRA, HAS, US FDA.
  • Proficient in Microsoft office
  • Familiar with software validation, SAP and Trackwise
  • Excellent written and verbal communication skills in both English
  • High attention to details, well organised and effectively manage multiple projects
  • Job title and salary offered will commensurate with experience & qualification.