(Senior) Director, Quality Assurance

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) Director, Quality Assurance

Responsibilities

  • As a member of the site leadership team to provide strategy and direction in Quality Assurance aspects within Tessa.
  • Responsible to lead and direct all aspects of Quality Assurance functions including Clinical Quality Assurance, Quality Systems Management, Supplier Quality Management, Quality Compliance and Batch Disposition.
  • Ensures that clinical studies are designed, conducted and reported according to applicable current GxP and regulations
  • Ensures that products are manufactured, processed, stored and distributed according to applicable current GxP and regulations
  • Ensures that facilities, equipment, materials, processes and procedures comply to applicable current GxP and regulations
  • Ensures Quality Management System is implemented, monitored and maintained
  • Reviews the Quality Management System and performance metrics to identify, report, address and correct quality issues
  • Ensures there is an adequate number of qualified personnel who have the appropriate combination of education, experience and training to perform assigned Quality Assurance responsibilities
  • Ensures Quality Assurance oversight for Quality Processes and disposition of raw materials and products
  • Serves as the site Quality Assurance representative to regulatory authorities and third party auditors
  • Alerts senior management of significant quality and compliance risks
  • Partners with cross-functional management to assure quality of products comply with applicable current GxP and regulations
  • Supports improvement initiatives, programs and projects of the Quality Management System

Requirements

  • Advanced Degree/Degree in Science, Pharmacy, Pharmaceutical Science, Engineering or equivalent with at least 15 years of relevant work experience in Quality Management role in the pharmaceutical/biotechnology/medical device industry
  • Extensive experience in leading and coaching quality teams with proven records in building teams
  • Extensive knowledge in regulatory requirements
  • Expertise in Quality Management System concepts
  • Excellent communication and leadership skills
  • A team player who is able to coordinate and interact with cross-functional departments, work independently and / or within team(s) with minimum guidance.
  • Able to multi-task and work in a fast-paced environment.
  • Highly motivated individual, with strong focus on safety, quality and deliverables.