Quality Operations, Associate Director/Senior 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 Operations, Associate Director/Senior Manager

Reports to
Head of Quality

Job Description:

  • Provide quality oversight to ensure manufacture of cell therapy products is in compliance with Company procedures and cGMP regulations.
  • Ensure that all activities related to establishing or improving manufacturing processes for cell therapy products comply with company procedures and cGMP regulations.
  • Manage (i.e. review and / or approve) manufacturing-related quality issues and investigations (e.g. deviations, trends, Out-of-Specification), to ensure their proper and timely completion, including that of the corresponding corrective and preventive actions (CAPA); and monitor effectiveness of implemented CAPAs.
  • Assess temporary and permanent changes from the manufacturing process and their impact on quality and regulatory compliance.
  • Participate as the ‘voice of quality’ in operational projects / tasks (e.g. manufacturing process and Master Batch Record improvement, product quality review, and process validation, etc.)
  • Participate in the general QA activities and assist in areas as regulatory submission / batch release / change assessment.
  • Perform review of GMP relevant documents for compliance with Standard Operating Procedures across different products.
  • Support risk assessment activities.
  • Acts as a Subject Matter Expert in process quality matters.
  • Contribute to the Annual product quality review.
  • Perform other ad-hoc quality duties as requested by manager.

Requirements:

  • Degree and above in Cell biology/ Biotechnology/ Microbiology/Biomedical Science/ Biochemistry or Science related field with at least 5 years of hands-on experience in cell therapy / Biologic product manufacturing GMP-regulated industries (Biotech preferred).
  • At least 3 years of experience in Quality Assurance and/or Compliance.
  • Good understanding of quality management principles.
  • Strong working knowledge of USFDA and other equivalent regulatory requirements as well as industry quality management tools, standards and quality systems.
  • Broad cGMP experience is preferred, with working knowledge and understanding of Production, Quality Control, and Validation requirements and activities.
  • Familiar with the statistical process control concepts.
  • Good understanding of critical process parameters. Good technical report writing skills.
  • Able to identify problems, troubleshoot and complete or coordinate corrective actions.
  • Possess good people management skills.
  • Strong planning and prioritization of activities for self and team without supervision.
  • Ability to communicate (both orally and written) effectively in professional manner with peers and management.
  • Excellent interpersonal and leadership skills, ability to work cross-functionally.
  • Excellent written and verbal communication skills in both English.
  • High attention to details, well organised and effectively manage multiple projects.