Manager, QC Systems

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, QC Systems

Reports To
Senior Director, Quality Control

Responsibilities

  • During the startup phase, to be the key and lead personnel in the implementation of Laboratory Information Management System (LIMS) for QC.
  • During the startup phase, to work as a main project lead for the equipment qualification activities in QC to ensure that the milestones for each equipment are being achieved as planned in order to support the site tech transfer activities.
  • During routine phase, to oversee QC Quality Systems related activities which include Lifecycle management of QC equipment, qualification, maintenance, periodic review, replacement and retirement of equipment, the maintenance of electronic systems/data from local/standalone systems, as well as serving as subject matter expertise for laboratory network and standalone system
  • To take on the application administrator role within QC.
  • To be the lead and expert in data integrity initiatives within QC. To lead or be involved in developing and driving data integrity initiatives and training within QC.
  • To be the equipment owner, if necessary, for any commonly used equipment that are not being dedicated to any specific test or operation.
  • Coach and guide QC personnel in developing their technical, GMP and leadership skills
  • Establish and maintain Quality Control policies or procedures that are essential for the QC Systems operations and control
  • Ensure regulatory and customer inspections readiness; represent area and participate in audits and inspections
  • Identify, develop, track performance metrics to effectively monitor laboratory performance and customer support.
  • Approve and authorize Quality Control procedures pertaining to QC Systems and any other QC operations, if applicable
  • Ensure the necessary training within the department is carried out and modified according to need.
  • 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 QC systems specialists by example and providing necessary coaching to the team to achieve efficient lab operations
  • To manage and be involved in all aspects of people management processes which include the selection, hiring and training of personnel on company and department policies, systems and processes. Manage and communicate compensation related information per company guidelines.
  • Coach and develop QC personnel by providing an environment that encourages personal and professional growth. Ensure that realistic personal goals are set for staff. Provide regular feedback throughout the year. Ensure staff receives appropriate knowledge and skills development for their career growth.
  • To timely alert function management of significant quality, compliance and safety risks
  • To bridge between function management and QC personnel and 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, Chemistry, Biochemistry, Biotechnology or equivalent
  • At least 5 – 7 years of working experience in QC function in bio/pharmaceutical industry and cGMP environment
  • Being in the leadership role for at least 3 years with demonstrated people management skills
  • Substantial experiences and knowledges in the following areas are required:
    • Relevant QMS & cGMP
    • Laboratory Information Management System (LIMS)
    • QC Equipment Qualification and Computer System Validation
    • Lab investigation and change management
    • Risk Assessment
  • Substantial knowledge in lab operations especially in supporting commercial GMP manufacturing
  • 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
  • Demonstrate strong leadership, communication and organization skills
  • Ability to interpret and relate Quality Standards for implementation and review
  • Able to work in a fast-paced environment, multi-task and undertake tasks timely & proactively