Sr. Specialist, Supplier Quality

InstilBio Inc, a cell therapy company focused on solid tumors, has recently acquired Immetacyte Ltd. InstilBio is developing patient specific immunotherapies in oncology, allowing the patient’s own immune system to be harnessed to fight cancer. The world-renowned team and its scientific advisors/investors have tremendous experience and track record in technology discovery, process development, GMP manufacturing and clinical operations with a track record of developing and gaining approval for successful cell therapies.

We have built upon the expertise of researchers who have successfully undertaken scientific and clinical research alongside Professor Robert Hawkins. Professor Hawkins is a leader in the field having undertaken several complex research projects and clinical trials involving: TIL, CAR-T, TCR based T cell therapies, cell selection, gene therapy, expansion of patient derived cells.

Recent significant investments in InstilBio are enabling the company to undertake Phase 2/3 to registrational clinical trials in melanoma.  Further trials are planned in other solid tumor indications and using gene-modified approaches to build a pipeline of TIL-based therapies.

Sr. Specialist, Supplier Quality

Instil Bio is seeking a driven and experienced Sr. Specialist, Supplier Quality.  The successful candidate will be a highly motivated individual with experience in Supplier Quality and implementation of the Supplier Quality principles, procedures, and processes. 

The candidates must be knowledgeable of vendor, supplier and material management process and systems.

In this role, the Sr. Specialist, Supplier Quality, is expected to support the Supplier Quality management program to ensure compliance with internal quality procedures and regulatory requirements. 

This position will routinely interact with Quality, Supply Chain, Procurement, Manufacturing to ensure and manage the quality of supplier goods produced by GMP suppliers, Contract Manufacturing Organizations (as applicable), and service providers.  This position will report to the Sr. Manager/Associate Director, Supplier Quality. 

Responsibilities (include but not limited to):

  • Support development and implementation of the Supplier Quality Management Program
  • Responsible for management/completion of supplier related documentation such as Supplier Quality Agreements (SQA), Supplier Corrective Action Report (SCAR), Supplier Questionnaires, Supplier Request for Information, and management of supplier-initiated changes
  • Assure all SQM related quality documentation and records are completed thoroughly and timely to maintain compliance
  • Maintain supplier audit schedule and approved supplier list
  • Coordinate, schedule, and perform supplier audits (including follow up on audit actions to ensure implementation compliance)
  • Track, trend, and report on meaningful SQM performance metrics (KPI) as well as Supplier performance metrics to Management
  • Collaborate with cross-functional stakeholders on matters pertaining to supplier controls, significant concerns related to Quality system performance, risk-based audit execution, issue escalation, procurement strategy and regulatory compliance  
  • Participate as a representative of SQM on project and/or investigation teams
  • Support inspection readiness plans and serve as Subject Matter Expert during regulatory inspections on SQM-related matters, as needed
  • Implement continuous improvement projects
  • Complete other responsibilities, as assigned

Requirements and Recommendations:

  • Bachelor’s Degree in Sciences, Engineering, or related field
  • Minimum of 6 years of Quality/Supplier Quality experience in a GMP environment (biotechnology, pharmaceutical, and/or cell therapy operations)
  • Travel may be required, up to 30 % (domestic and international)
  • It is critical that you have:
    • In-depth knowledge of and ability to apply GMP in conformance to the US and EU
    • Experience working and direct interface with regulatory agencies
    • Experience writing, evaluating, and closing investigations, CAPAs and change control records
    • In-depth understanding with vendor, supplier and material management process and systems
    • Experience with Quality Risk Management principles
    • Good technical report writing skills
  • It is strongly encouraged that this role have:
    • ASQ’s Certified Supplier Quality Professional (CSQP)
    • Understanding and experience of cell therapy processes
    • Facility start-up or quality systems/SQM implementation experience
  • Personal Skills:
    • Self-motivated, technically driven, and willing to take on duties outside of general responsibilities
    • Excellent critical thinking, analytical, and problem-solving skills
    • Excellent interpersonal, influencing, verbal, and written communication skills
    • Ability to work effectively in a dynamic, complex, and fast paced team environment
    • Demonstrated ability to multi-task effectively and adjust workload based on changing priorities
    • Ability to work independently and with minimal supervision
    • Demonstrated planning & organizational skills
    • Proficient in MS office applications/software
    • Demonstrated ability to train and coach others