(Senior) Specialist, Quality Assurance

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation cell therapies for cancer. It has a pipeline of therapies in clinical development for the treatment of hematological malignancies and solid tumors.

Tessa’s lead autologous therapy is in late-stage clinical development for treatment of lymphomas. It has shown strong clinical responses in patients with relapsed/refractory classical Hodgkin lymphoma, based on which it was granted the RMAT designation by the U.S. FDA and the PRIME designation by EMA.

Tessa is also developing a novel, differentiated, allogeneic “off-the shelf” cell therapy platform to create more efficacious, reliable, and scalable therapies capable of targeting a broad range of cancers. A therapy using this platform is being evaluated in an ongoing clinical trial in United States.

Job Position
(Senior) Specialist, Quality Assurance

Responsibilities

  • Responsible for providing QA support to manufacturing operations in a cell therapy facility.
  • Lead/ participate in quality monitoring of manufacturing cleanrooms, warehouse, utility areas and Quality Control laboratories.
  • Provide real-time resolutions on process events on the floor in accordance to established site procedures.
  • Review of executed manufacturing batch records for completeness and compliance to cGMP requirements.
  • Ensure timely disposition/ release of incoming raw materials and final product.
  • Provide QA oversight of deviations, investigations, change controls and CAPA plans, and to ensure timely closure of these records.
  • Participate and contribute actively in cross-functional investigations such as in the event of environmental monitoring excursions or OOS.
  • Review and final approval of cGMP documents such as SOPs, batch records, logbooks, protocols and reports.
  • Provide QA oversight of validation and periodic review of facility, utility systems and equipment.
  • Initiate and coordinate gap assessment to ensure site compliance to regulatory requirements.
  • Adhere to data integrity requirements for paper and electronic documentation
  • Provide support to documentation control activities such as document reconciliation and archival.
  • Conduct training as subject matter expert in quality-related topics as assigned.
  • Assume the role of business process owners for quality systems such as SAP and EDMS.
  • Participate in internal and external audits /inspections.
  • Support improvement initiatives, programs and projects driven from the Quality Management System.
  • Escalates quality and compliance risks to QA Management.

Requirements

  • Bachelor or Master’s degree in Science, Pharmacy, Pharmaceutical Science, Engineering or equivalent with preferably more than 3 years of relevant work experience in Manufacturing or Quality Assurance in the pharmaceutical/ biotechnology/ medical device industry.
  • Knowledge in biologics and/or aseptic manufacturing is preferred.
  • Good understanding of cGMP requirements on manufacturing operations.
  • Possess knowledge and experience in quality management system in a cGMP facility.
  • Familiarity with regulatory requirements pertaining to aseptic processing is preferred.
  • A team player who is able to coordinate and interact with cross-functional departments, work independently and / or within team(s) with minimum guidance.
  • Able to multi-task and work in a fast-paced environment.
  • Highly motivated individual, with strong focus on safety, quality and deliverables.