Quality Manager

Company Background

Tessa Therapeutics is a clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells. Tessa’s core virus-specific T Cell (VST) platform has shown compelling results in the treatment of solid tumors, and the company is building a portfolio of therapies addressing a wide range of tumors by combining the qualities of its T cell platform with complementary technologies. Tessa’s lead Phase III trial for nasopharyngeal carcinoma (NPC) is the world’s largest Phase III T cell immunotherapy trial for any cancer indication. The company has built up robust operational and supply chain capabilities to successfully deliver autologous T cell therapy treatments to a large patient pool across five countries. The combination of technologies from its academic, clinical, and commercial research partners have enabled the company to create a fully-integrated approach to the treatment of cancer with immunotherapy.

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

Reports to
Associate Director, Quality Assurance

Job Description

  • Managing of QA documentation and stability testing protocol
  • Follow up on change control, deviation, investigation, corrective and preventive actions
  • Provide support in QC activity
  • 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