Associate Director/ Senior Manager, Quality Assurance (Quality Operations)

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
Associate Director/ Senior Manager, Quality Assurance (Quality Operations)

Job Description

  • Responsible to lead the Quality Operations team within Tessa Singapore Manufacturing Operations (TSMO) in providing quality oversight in manufacturing, QC, warehouse operations, engineering, validation etc according to applicable current GxP and regulations and to ensure that facilities, equipment, materials, processes and procedures comply with applicable current GxP and regulations.
  • Responsible in the review of batch records and ensure lot disposition is performed as per plan.
  • This role will also be expected to serve as sterility assurance lead for TSMO and ensuring that the site is in compliance with the regulatory requirements for sterile manufacturing.
  • Implements, maintains and reviews the assigned Quality Process according to applicable current GxP and regulations
  • Owns policies and procedures of the assigned Quality Process
  • Partners with and communicates to functions to ensure the assigned Quality Process is executed according to established policies and procedures
  • Reviews/approves and provides inputs for procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process
  • Ensures deviations from assigned Quality Process are documented and investigated
  • Ensures QA personnel are qualified and trained to perform assigned tasks
  • Develops strategies for assigned Quality Process to ensure a state of inspection readiness
  • Supports inspection and audit preparations
  • Escalates quality and compliance risks to Head of Department, QA
  • Supports improvement initiatives, programs and projects of the assigned Quality Process

Requirements

  • Advanced Degree/Degree in Science, Pharmacy, Pharmaceutical Science, Engineering with preferably 8-10 years of relevant working experience in Quality Management System in the pharmaceutical/biotechnology/medical device industry
  • With some knowledge and experience in Cleanroom Qualification, Aseptic Simulation Processing (APS), Microbiological Methods Validation/Suitability will be preferred.
  • Extensive knowledge in Quality Management System concepts
  • Good communication skills
  • Excellent oral and written communication skills