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(Senior) Specialist, Quality Assurance
2 weeks ago
**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 (QMS)
- Establish Quality Management Systems and other QA Processes as assigned
- Coordinate/Facilitate Quality Council Meeting
- Coordinate/Facilitate Annual Product Review Report
- 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
- Provide QA oversight of the assigned Quality Process to ensure that facilities, equipment, materials, processes and procedures comply to applicable current GxP and regulations
- Maintain the assigned Quality Process according to applicable current GxP and regulations; develops and executes strategies for assigned Quality Process to ensure a state of inspection readiness
- Assume the role of business process owner for quality systems such as EQMS.
- Partner with functions to ensure the assigned Quality Process is executed according to established policies and procedures
- Review / approve and provide inputs for procedures, documents, records, deviations, investigations, corrective actions / preventive actions, change controls and gap assessments associated with the assigned Quality Process. May also support execution of these tasks.
- Ensure deviations from assigned Quality Process are documented and investigated
- Lead and participate in internal and external inspections / audits, and Quality Management Review / Quality Council forum
- Initiate and coordinate gap assessments with functions to ensure site compliance to regulatory requirements.
- Ensure quality risks identified are tracked and corresponding mitigation plans are in place and monitored on their execution progress
- Communicate quality and compliance risks to site management and relevant stakeholders
- Support inspection and audit preparations
- Drive and/or support improvement initiatives, programs and projects of the assigned Quality Process
**Requirements**:
- Advanced Degree/Degree, Diploma in Science, Pharmacy, Pharmaceutical Science, Engineering
- Preferably more than 3 years of relevant working experience in Quality Assurance in the pharmaceutical/biotechnology/medical device industry
- Good understanding of cGMP requirements (and up-to-date on relevant regulatory / industry trends) with knowledge in regulatory requirements (with experience in HSA, FDA, EMA or MHRA Cell & Gene therapy or ATMP regulatory requirements)
- Knowledge in Quality Management System concepts
- Knowledge in biologics, aseptic manufacturing preferred
- Experience in conducting audits (to GxP and regulations) would be advantageous
- Team player with good interpersonal skills who is able to coordinate and collaborate with cross-functional departments, work independently and / or within team(s) with minimum guidance.
- Strong critical and logical thinking skills
- Able to multi-task and work in a fast-paced environment.
- Excellent written and verbal communication skills
