Principal/ Senior Expert, Quality Assurance (QMS)

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
Principal/ Senior Expert, Quality Assurance (QMS)

Job Description

  • Establish Quality Management Systems and QA Processes during the startup phase.
  • Provides QA oversight of the assigned Quality Process to ensure that products are processed, manufactured, stored and distributed according to applicable current GxP and regulations
  • Provides QA oversight of the assigned Quality Process to ensure that facilities, equipment, materials, processes and procedures comply to applicable current GxP and regulations
  • Maintains the assigned Quality Process according to applicable current GxP and regulations
  • Partners with 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. May also support execution of these tasks.
  • Ensures deviations from assigned Quality Process are documented and investigated
  • Ensures QA personnel are qualified and trained to perform assigned tasks
  • Supports inspection and audit preparations
  • Participates in inspections, audits and Quality Management Review
  • Escalates quality and compliance risks to Head of Department, QA
  • Supports improvement initiatives, programs and projects of the assigned Quality Process
  • Develops strategies for assigned Quality Process to ensure a state of inspection readiness

Requirements

  • Advanced Degree/Degree, Diploma 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
  • Knowledge in regulatory requirements (with experience in HSA, FDA, EMA regulatory requirements)
  • Knowledge in Quality Management System concepts
  • Knowledge in biologics, aseptic manufacturing preferred
  • Teamplayer with strong collaboration mindset and good interpersonal skills
  • Strong critical and logical thinking skills
  • Excellent written and verbal communication skills