Manager, Quality Control

About Tessa Therapeutics

Tessa Therapeutics is a clinical-stage cell therapy company focused on the development of autologous and off-the-shelf, allogeneic therapies to treat cancer. Tessa’s Virus-Specific T cell (VST) technology platform harnesses the body’s potent anti-viral immune response and has shown early efficacy and a strong safety profile against solid tumors in clinical trials.

Tessa is building a portfolio of innovative, next-generation therapies through combination approaches and other novel immuno-oncology technologies. This portfolio includes a rapidly growing clinical pipeline that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, head and neck cancer, and lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver 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 global team of over 200 employees is passionate about bringing life-saving cancer treatments to patients all over the world. If this excites you too, explore our job opportunities and see if there’s a match.

For more information on Tessa, please visit www.tessatherapeutics.com.

Job Position
Manager, Quality Control

Reports To
Associate Director, Quality Control

Responsibilities

  • To ensure QC release testing is performed on finished products according to relevant procedures meeting business needs and department performance KPI
  • To ensure site-specific QC lab operations pertaining to lab equipment, computer system, sample logistics, test methods & procedures and QC analysts are appropriately qualified, validated and trained respectively as phase appropriate in accordance to cGMP requirements and local EHS regulations
  • To draft and / or review site-specific QC documents including SOPs, work sheets, protocols
  • To manage lab operations associated QMS activities timely and systematically including but not limited to: deviation, OOS, change control, investigations, CAPA, inspection and other lab-related issues where applicable
  • To actively join and support cross-functional project(s), regulatory submission and company-wide initiatives as assigned by supervisor and/or department head
  • To lead and manage a team of analysts by example and providing necessary coaching to the team to achieve efficient lab operations
  • To timely alert function management of significant quality, compliance and safety risks
  • To bridge between function management and QC analysts ensuring open & clear communication and alignment within department
  • To promote a cohesive and conducive working environment in QC through close interaction with team members
  • Perform any other ad-hoc duties as assigned by superior

Requirements

  • Bachelor’s or Master’s degree holder in Biology, Life Science, Biochemistry, Biotechnology, Bioengineering or equivalent
  • At least 8 – 10 years of working experience in QC function in bio/pharmaceutical industry and cGMP environment
  • Being in the leadership role for at least 6 years with demonstrated people management skills
  • Substantial experiences and knowledges in the following areas are required:
    • QMS & cGMP
    • Pharmacopeia test methods for Cell, Gene & Tissue based products
    • Lab investigation and change management
    • Risk Assessment
    • TrackWise, SAP and LIMS computer systems
  • Growth mindset, able to think strategically when dealing with challenges and solving problems
  • A team player with excellent coordinating & organizing skills, able to work independently and / or within team(s)
  • Proficient in both written and verbal presentation and communication, able to communicate with clarity and openly
  • Ability to lead by example
  • Able to work in a fast-paced environment, multi-task and undertake tasks timely & proactively
  • Knowledge and experience in the following areas are advantageous:
    • Cell culture or flow cytometry or immunostaining or ELISA
    • Continuous Improvement
    • Lean operation