Senior Manager, Quality Assurance (Supplier Management)

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 Manager, Quality Assurance (Supplier Management)

Responsibilities

  • Responsible to lead the quality system/processes associated with Supplier Quality Management (including Supplier Qualification, Supplier Audits and Quality Agreements management), Materials Assessments and Qualification.
  • Provides QA oversight of the quality processes as mentioned above according to applicable current GxP and regulations and to ensure that facilities, equipment, materials, processes and procedures comply with applicable current GxP and regulations
  • Manage the approved suppliers list for local, global sites (including CMO, apheresis centers, testing labs, logistics service providers etc)
  • 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
  • Work closely with a cross functional team to quickly mitigate and deploy decisive actions, solve supplier and raw material issues, focusing on supplier continuous improvements and reducing risk to our supply chain
  • 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
  • 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

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
  • Knowledge in regulatory requirements
  • Extensive knowledge in Quality Management System concepts
  • Excellent oral and written communication skills
  • Quality lead auditor role preferred, especially for leading supplier audits
  • Knowledge in biologics, aseptic manufacturing preferred
  • May require up to 50% travel (subjected to travel regulation)