Senior Executive, Quality Assurance

Company Background

Tessa Therapeutics is a clinical-stage immunotherapy company focused on the development of autologous and off-the-shelf, allogeneic therapies targeting solid tumors. Tessa’s Virus-Specific T cell (VST) platform harnesses the body’s potent anti-viral immune response and has shown compelling results in the treatment of solid tumors.

Tessa is building a portfolio of innovative, next-generation therapies by combining the qualities of VSTs with other immuno-oncology technologies. This includes a rapidly growing pipeline of clinical and pre-clinical autologous programs that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, as well as head and neck cancer. In addition, Tessa is leveraging its platform to develop an allogeneic therapy to address Epstein-Barr virus (EBV)-associated lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver T cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created 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 team.

Job Position
Senior Executive, Quality Assurance

Reports To
Senior Manager, Quality Assurance

Job Description

  • Support/participates as a QA representative for Quality Operations activities, including review and/or approval of GMP relevant documents not limited to batch records, SOP, reports etc.
  • Deviation/OOS/Customer Complaints: Participates in investigations, reviews and approves investigation reports, Tracks Corrective Actions/Preventive Actions, Generates deviation summary reports, etc.
  • Change Control: Reviews and approves change control request, qualification activities from quality perspective. Acts as Quality representative in change control meetings.
  • To independently solve problems that arise within job responsibilities and expectation; organize information in a logical way and combine data and information from multiple sources in new ways to determine causes of issues by applying knowledge of technical and scientific knowledge, statistical data evaluation.
  • Support, lead, serves as a QA representative for network initiatives, alignments and best practices implementation
  • Support in developing and overseeing plans for all activities related to local/regional deviation management projects including connection to product recalls and clinical stock recoveries.
  • Maintains appropriate quality oversight of SOPs for manufacturing and operational activities.
  • Drafts, gain approval and execute SOPs, plans and Quality Systems implementation initiatives
  • Participates and supports audit related activities
  • To prepare training materials and conduct training as part of the QA related implementation initiatives
  • To work alongside and support supervisor/manager by ensuring effective communication within the team
  • Serves as a lead for Quality initiated programs
  • To support other QA/Site operation activities when required.
Requirements
  • Bachelor’s degree in Life Science/Science/Pharmaceutical Science/ Chemical Engineering or equivalent with at least 4-6 years of working experience in a Quality and preferably cGMP pharmaceutical manufacturing environment, supplying to FDA and/or EMA regulated markets.
  • Have a basic understanding of Lean and Six-Sigma. A certification in Six Sigma Green Belt is an added advantage. Requires a continuous improvement mindset.
  • Good knowledge and understanding of GMP and application of pharmaceutical regulatory requirements
  • Audit experience is preferred. Good knowledge of Singapore, US and EU regulatory requirements
  • Able to work with people from different background and levels
  • Being open-minded, resourceful and able to think strategically when dealing with challenges and solving problems
  • A good team player with excellent planning, coordination and inter-person skills
  • Attention to details and able to undertake tasks timely and proactively
  • Foster positive team environment by being inclusive
  • Proficient in technical writing and presentation
  • Able to work in a fast-paced environment and manage multiple projects