Senior Manager, Quality Assurance Validation

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 team.

 

Job Position

Senior Manager, Quality Assurance Validation

Reports to

Director, Quality

Job Description

Provide QA oversight for Qualification and Validation activities at Tessa Manufacturing site(s) with the following core responsibilities:

  • Setup/be part of the QA validation team to support all aspects of qualification and validation program, including qualification & re-qualification of process and testing equipment, manufacturing process, QC testing, shipping, etc.
  • Develop, review and approve validation and qualification strategies for manufacturing facility, processes, cleaning, shipping and equipment, including supporting risk assessments.
  • Provide QA expertise to assess impacts and support investigations, deviations, CAPAs related to validation / engineering processes.
  • Provide oversight for validation / engineering related cGMP documents including, but not limited to validation plans, SOPs, work instructions, templates, guidelines, protocols, summary reports and ensure consistency and compliance with regulatory requirements.
  • Review and approve facility and equipment related change controls, including the assessment for equipment criticality, calibration / PM program.
  • Create Validation Master Plan and ensuring that the Company’s Validation Master Plan is up to date, maintaining the validation life cycle of the manufacturing facility.
  • Manage site validation documentation program, validation vendor management and maintenance.
  • Provide leadership and guidance to staff on qualification / validation matters. Directs efforts to ensure efficient and effective systems are maintained and continuously improved.
  • Participate in continuous improvement efforts in quality systems through the evaluation of trends in key performance indicators, audit and stakeholder feedback, and corrective / preventive actions.
  • Provide support as needed in the regulatory audits / inspections or meetings.
  • Perform other ad-hoc duties as requested by manager / supervisor.

Requirements

  • Degree and above in Cell biology/ Biotechnology/ Microbiology/Biomedical Science/ Biochemistry or Science related field with at least 8 years of hands-on experience in GMP-regulated cell therapy / biologic product manufacturing industries
  • At least 3 years of experience in Quality Assurance and / or Compliance, including oversight for validation projects across the various validation activities from initial planning stage up to the eventual report summary stage.
  • Extensive knowledge of cGMP requirements, with working knowledge and understanding of Validation, Production, Quality Control requirements and activities preferably in equipment / process validation, shipping validation, QC method validations, facility qualifications, etc.
  • Strong working knowledge of US FDA and other equivalent regulatory requirements.
  • Mastery and knowledge of quality principles and cGMP guidelines.
  • Good understanding of validation principles and critical process parameters.
  • Ability to identify problems, troubleshoot and complete or coordinate corrective actions.
  • Strong planning and prioritization of activities for self without supervision.
  • Ability to write & communicate effectively in a professional manner with peers, management and other functional groups.
  • High attention to details, well organized and can effectively manage multiple projects.
  • Good people management skills with ability to work cross-functionally.