Manager, Quality Control (Environmental Monitoring)

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
Manager, Quality Control (Environmental Monitoring)

Reports To
Senior Manager, Quality Control

Responsibilities

  • Lead the QC Environmental Monitoring (EM) Team and QC Lab Support (LS) Team
  • Responsible in ensuring all equipment and methods used for EM are being qualified and/or validated for their intended use.
  • Responsible in ensuring that the EM Program is being implemented as per plan.
  • Responsible in ensuring that the EM trend reports are being developed and the trend information is being shared with the site Quality team. Ensure that any adverse trends are being escalated appropriately.
  • Drives corrective/preventative actions, ensuring work is complete and the site remains in a state of control.
  • Responsible for ensuring laboratory compliance and data integrity in all areas within the scope of EM and LS.
  • Lead the QC Lab Support Team which supports areas such as Sample Management, Sample Shipment Coordination, QC inventory management, Stability Samples Management and reagents preparation.
  • Ensure the necessary training within the department is carried out effectively.
  • Acts as an advisor to subordinates when determining how to meet schedules and/or resolve technical problems. Reviews records for accuracy and compliance with cGMP and Tessa policies and SOPs.
  • Lead/participate in EM excursion investigations. Ensures corrective actions identified for the investigation are implemented in a timely manner and monitored as part of the monthly trending meetings.
  • Writes, reviews, and/or approves SOPs, sampling plans, and protocols.
  • Provides technical expertise in the areas of environmental monitoring.
  • Proactively evaluate the laboratory’s quality systems for gaps in current compliance standards and/or industry trends for compliance. If gaps are identified, mitigate these gaps.
  • Approve and authorize specifications, sample instructions, methods and other Quality Control procedures, including changes
  • Proactively develop staff. Coach and provide feedback on job performance. Complete annual performance evaluations and identify development opportunities. Sets and delivers on individual and team goals that support the department and site strategy. Assist with training new hires and cross-train existing staff.
  • Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).
  • Develops and monitors team performance measures to understand effectiveness, efficiency, and quality of group performance.
  • Identify, develop, track performance metrics to effectively monitor laboratory performance and customer support.
  • Monitors and evaluates current regulatory requirements, making recommendations for improvements when necessary.
  • Excellent communication, interpersonal and organizational skills.
  • Work well both independently and in a team environment.
  • The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Requirements

  • Degree in life science discipline or any related field with at least 5 years of relevant working experience in a highly regulated cGMP regulated environment (Biologics and Pharmaceuticals etc) with at least 2 years of supervisory experience.
  • Good understanding of current regulatory requirements of GMP Biologics and Pharmaceutical industries.
  • Experience with cleanroom environmental monitoring especially in the areas of aseptic GMP manufacturing.
  • Demonstrate strong leadership, communication and organizational skills
  • Experience with technical investigations.
  • Ability to prioritize work and multitask.
  • A demonstrated ability to supervise, train, and manage technical staff.
  • cGMP audit experience in USFDA, EU and HSA etc.