Manager, Supplier Quality Assurance

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

Manager, Supplier Quality Assurance

Reports to

Associate Director, Quality Assurance

Job Description

  • Responsible for oversight of the company’s supplier quality program, including the selection, evaluation and performance monitoring of suppliers.
  • Ensure highest quality and compliance of suppliers of incoming materials, and service providers engaged by the Company.
  • Develop and lead the supplier qualification (and re-evaluation) program, ensuring full compliance to regulatory and company requirements.
  • Support technical and end-user teams in the selection of potential suppliers as necessary.
  • Monitor performance of suppliers; ensure investigations related to supplier quality issues or suppliers’ complaints are completed with assignable root cause(s) established and CAPAs implemented in a timely manner.
  • Develop quality agreements with suppliers and ensure updates are made to them whenever applicable.
  • Evaluate supplier change notifications and drive corresponding supplier change notification review by functional areas until change implementation is completed.
  • Review and maintain the Approved Supplier List including supplier qualification status and the corresponding material specifications.
  • Plan Annual Audit Schedule for Suppliers and ensure such audits are performed as per plan and subsequently reported on the audit outcome. Ensure timely completion and update all CAPAs resulting from supplier audits.
  • 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 3 years of hands-on experience in regulated pharmaceutical industries and / or regulatory agencies.
  • Minimum 2 years in supplier quality management.
  • Good understanding of quality management principles; minimum of 2years in leading quality audits (preferably 3rd party and / or 2nd party) with ASQ Certified Quality Auditor (CQA) or other equivalent international certification desirable.
  • Strong working knowledge of US FDA and other equivalent regulatory requirements as well as industry quality management tools, standards and quality systems.
  • Broad pharmaceutical experience is preferred with working knowledge and understanding of production, Quality Control and Validation requirements and activities.
  • Able to identify problems, troubleshoot and complete or coordinate corrective actions.
  • Strong planning and prioritization of activities for self and team without supervision.
  • Ability to communicate (both verbally and written) effectively in professional manner with peers and management.
  • Excellent interpersonal and leadership skills, ability to work cross-functionally
  • High attention to details, well organized and effectively manage multiple projects.
  • Good people management skills.
  • Able to travel at least 20% of the time.