(Senior) Specialist, Quality Assurance (Supplier Quality)

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 (Supplier Quality)

Job Description

  • Responsible for providing QA support to Supplier Quality Management for purchased materials and outsourced/contract activities, including new supplier qualification, routine vendor monitoring and reassessment, Supplier Audits and Quality Agreements management.
  • Perform qualification and risk assessment for purchased materials and/or services that impact the product’s quality, integrity, efficacy and safety, prior GMP commercial manufacturing use.
  • Manage the approved suppliers list for local, global sites (including CMO, apheresis centers, testing labs, logistics service providers etc)
  • Implements, maintains and reviews the assigned Quality Process according to applicable current GxP and regulations, ensure appropriate level of control is implemented on supplier.
  • Manages vendor change notification, supplier complaint and provide vendor performance data trend to support site investigation/quality management review.
  • Review and update of site GMP documents (e.g: SOPs, vendor master list and material specifications) and maintain the supplier documents throughout the supplier lifecycle.
  • Participate and contribute actively in cross-functional investigations for the event related to vendor’s deviations, investigations, change controls and CAPA plans and ensure timely closure of these records to support manufacturing activities.
  • Initiate and coordinate gap assessment to ensure site compliance to regulatory requirements.
  • Adhere to data integrity requirements for paper and electronic documentation
  • 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.
  • Any other tasks as and when assigned by manager.

Requirements

  • Bachelor or Master 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.
  • Good understanding of cGMP requirements.
  • Knowledge in biologics, aseptic manufacturing preferred
  • Possess knowledge and experience in quality management system in a cGMP facility and vendor qualification/oversight vendor quality process.
  • Quality auditor role preferred, especially for supplier audits
  • A team player who is able to coordinate and interact with cross-functional departments, work independently and / or within team(s) with minimum guidance.
  • Highly motivated individual, with strong focus on safety, quality and deliverables.