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.
Principal/ Senior Expert, Quality Assurance (QMS)
- 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
- 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