Senior Director, Quality

Senior Director, Quality (Cell & Gene Therapy) Salt Lake City, UT | Onsite This is a Head of Quality role with full ownership across QA, QC, and Microbiology in a lean, high-impact environment. The Opportunity This is a chance to step into a build-and-scale leadership role where you'll directly shape quality strategy, infrastructure, and execution as the organization transitions from clinical to commercial. You'll work closely with executive leadership and cross-functional teams to ensure the organization is fully prepared for regulatory submission and inspection readiness. What You'll Be DoingLead and oversee Quality Assurance, Quality Control, and Microbiology functionsOwn and enhance a GMP-compliant Quality Management System (QMS)Drive inspection readiness efforts and support regulatory interactions (FDA, global authorities)Provide oversight of batch record review, release, and manufacturing qualityPartner cross-functionally across Manufacturing, CMC, and Technical OperationsSupport BLA readiness and submission activitiesBuild, mentor, and scale a growing Quality organizationLead implementation/optimization of systems (e.g., eQMS, LIMS) What They're Looking For10+ years in Quality within biologics, cell therapy, gene therapy, or related biopharmaProven leadership experience across QA and QC (Microbiology a plus)Strong background in GMP environments and regulatory complianceExperience supporting late-stage clinical programs and/or commercialization readinessExposure to regulatory submissions (BLA preferred) and inspection readiness/PAIAbility to operate in a hands-on, fast-paced, startup environment Key ConsiderationsLocation: Salt Lake City, UT (onsite expected) Compensation: Base salary up to ~$225K, plus equity Environment: Pre-revenue biotech, lean team, high ownership Why This RoleTrue Head of Quality ownership, not a layer under multiple levelsOpportunity to build and shape systems, teams, and processesDirect visibility with executive leadershipPositioned at a critical inflection point toward regulatory approval and commercialization