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Senior Director, Quality

Seattle, WA

About GentiBio

GentiBio is an emerging biotherapeutics company co-founded by pioneers in Treg biology and synthetic immunology from Seattle Children’s Research Institute, Benaroya Research Institute, and MIGAL Galilee Research Institute. GentiBio is focused on the development of EngTregs programmed to treat autoimmune, alloimmune, autoinflammatory and allergic diseases. GentiBio’s proprietary autologous and allogeneic EngTregs platform integrates key complementary technologies needed to successfully restore immune tolerance and overcome major limitations in existing regulatory T-cell therapeutics.

GentiBio is seeking to build an organization with an exceptional company culture focused on empowerment, care for our team members, an appreciation for diversity and inclusion, and the development of our people. As such, we are looking for candidates who are not just great scientists but individuals who are looking to contribute to building and modeling an outstanding company culture – and having fun while doing so.

GentiBio is building corporate operations in both Boston and Seattle. We are looking for outstanding leaders and scientists to join our team in both of our locations.

Job Summary

GentiBio is seeking a collaborative and self-driven Quality leader to join our Technical Operations team in Seattle as the Senior Director of Quality. The successful candidate will be responsible for providing leadership oversight to all Quality Assurance, Quality Control, and Product Quality activities at GentiBio, including external suppliers and CDMO partners. This role offers exposure to multiple facets of an organizational and company build, a prominent leadership role within Technical Operations and the company at large, and ample opportunities to be a high impact trailblazer in the emerging field of regulatory T-cell therapy.

Job Responsibilities

  • Foster the culture of seeking and giving help, inclusion, authenticity, and fun
  • Establish and lead the CMC Quality organization at GentiBio. This includes:
    • Provide exceptional leadership to the organization and oversight of Quality Assurance, Quality Control, and Product Quality activities
    • Use strong communication and teamwork skills to build strong relationships with stakeholders inside and outside of GentiBio
    • Demonstrate outstanding technical acumen by using knowledge of Quality requirements to ensure high-level of GMP compliance in all Quality operations
    • Create a culture of quality and compliance within the TechOps organization
  • Develop GentiBio’s Quality Control Management System
  • Develop Quality Assurance processes to enable effective product development
  • Develop phase-appropriate Quality system strategy with a clear plan to scale systems as the organization grows and clinical pipeline advances to late stage
  • Ensure all compliance documents, procedures, and processes are properly identified, drafted, and approved
  • Lead all aspects of development of Quality Systems with an emphasis on paperless eSystems to support GentiBio’s pipeline consisting of both engineered autologous and allogeneic cellular therapeutics
  • Serve as a key leader and decision maker on project teams and steering committees
  • Play a key leadership role in the selection and oversight of suppliers and CDMO partners
  • Support the development of all necessary quality plans, risk assessments, strategy documents, and regulatory assessments
  • Work closely with TechOps peers in Process Development, Analytical Development, CMC Lifecycle Management, Patient Operations, and CMC Regulatory to ensure high level of compliance with regulatory requirements and expectations
  • Serve as the senior Quality leader in charge of all critical Quality decisions
  • Grow an organization composed of QA and QC leaders
  • Contribute Quality expertise to due diligence, audits, and collaboration initiatives

Educational Qualifications and Requirements

  • B.S./M.S./Ph.D. in a relevant Science or Engineering discipline with 15+ years of relevant industry experience
  • Previous experience in a strategic leadership role as a Quality leader in a cell therapy operation
  • Ability to synthesize multiple inputs into key CMC deliverables
  • Experienced at designing, implementing, and managing quality systems
  • Prior experience serving as a key contributor to regulatory filings
  • Previous experience with CDMO management and gene edited T-cell products preferred
  • Excellent communication and organizational skills
  • Adaptability and demonstrated ability to work collaboratively with others to solve complex programs
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