Manager/Sr. Manager, Quality Compliance

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.

Manager/Sr. Manager, Quality Compliance, Quality Assurance

Instil Bio is seeking a driven and experienced Quality Compliance Manager/Sr. Manager.  The successful candidate will have proven leadership, provide quality audit and regulatory compliance expertise for pharmaceutical manufacturing and quality processes and related products.  Candidate will be responsible for enforcing regulations in all aspects and levels of business as well as provide guidance on compliance matters.        

The candidate must be knowledgeable and ensure internal site compliance to applicable regulations, standards, and quality systems and through direct interactions across all functional lines and periodic auditing.

In this role, the Manager/Sr. Manager will be expected to establish guidelines and requirements for quality and regulatory compliance in support of special projects and ongoing operations.  

This position will routinely interact with other Quality Assurance functions, Quality Control, Manufacturing, Supply Chain, Engineering/Facilities.  This position will report to the Director, Quality Assurance.

Responsibilities (include but not limited to):

  • Implement the quality compliance processes and systems
  • Promote a culture of Quality Compliance on site
  • Manage a team of Quality Compliance professionals
  • Manage the inspection readiness program and lead/host external audits from Regulatory Authorities
  • Manage responses and leads efforts for CAPA/lessons learned from audits and inspections
  • Ensures compliance with regulatory commitments
  • Manage the site self-inspection and annual internal audit programs
  • Oversee compliance with InstilBio standards and procedures
  • Manage the site Quality Council Process and escalate Quality Compliance concerns to the Site Leadership Team
  • Manage the site Customer Complaint process
  • Perform Compliance gap assessments
  • Develop, manage, and report on compliance Key Performance Indicators during Management Review meetings
  • Act as key site contact for regulatory affairs queries and discussions.
  • Support preparation of documentation for regulatory submission
  • Liaise with other departments on Quality issues (as required), providing guidance and support as required
  • Work closely with other site Quality Managers and assume responsibilities in any of the Quality Department pillars in accordance with business needs.
  • Complete other responsibilities, as assigned

Requirements and Recommendations:

  • Bachelor’s degree in Sciences, Engineering, or related field   
  • 5-8 years’ experience in the pharmaceutical industry in a Quality role and experience in a GMP environment (biotechnology, pharmaceutical, and/or cell therapy operations)
  • It is critical that you have:
    • Extensive knowledge of and experience of GxP regulations, quality systems, and regulatory guidance documents in US and EU and ability to use judgement and knowledge to determine appropriate quality systems compliance.
    • Experience leading internal audits and regulatory inspections 
    • Experience working and direct interface with regulatory agencies
    • Ability to work in controlled & classified environment requiring donning of cleanroom garments (e.g., gowns, gloves, booties, hoods/masks, etc.)
    • Clinical manufacturing and/or commercial manufacturing experience
  • It is strongly encouraged/preferred that this role have:
    • Understanding and experience of cell therapy processes
    • Knowledge/experience in aseptic manufacturing processes and procedure  
    • Working knowledge of core quality processes, including raw material disposition, chance control, product complaints, deviations, investigations and CAPA management
  • Personal Skills:
    • Excellent knowledge of Good Manufacturing Practice as described in current FDA, EMEA and ATMP regulations for sterile, and biological pharmaceutical manufacture
    • Ability to act as Subject Matter Expert for aseptic pharmaceutical manufacture
    • Demonstrable experience managing, motivating, and leading a team.
    • A high level of initiative
    • Excellent interpersonal, verbal, and written communication skills
    • Strong project management and organizational skills.
    • Ability to adapt to changing priorities
    • Demonstrated problem-solving and critical thinking skills
    • Strong courage of conviction and conflict resolution skills
    • Ability to work effectively in a dynamic, complex, and fast paced team environment
    • Excellent leader with strong coaching and mentoring skills
    • Demonstrated ability to multi-task effectively and adjust workload based on changing priorities
    • Self-motivated, technically driven, and willing to take on duties outside of general responsibilities