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 Doing Lead and oversee Quality Assurance, Quality Control, and Microbiology functions Own 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 quality Partner cross-functionally across Manufacturing, CMC, and Technical Operations Support BLA readiness and submission activities Build, mentor, and scale a growing Quality organization Lead implementation/optimization of systems (e.g., eQMS, LIMS) What They’re Looking For 10+ years in Quality within biologics, cell therapy, gene therapy, or related biopharma Proven leadership experience across QA and QC (Microbiology a plus) Strong background in GMP environments and regulatory compliance Experience supporting late-stage clinical programs and/or commercialization readiness Exposure to regulatory submissions (BLA preferred) and inspection readiness/PAI Ability to operate in a hands-on, fast-paced, startup environment Key Considerations Location : Salt Lake City, UT (onsite expected) Compensation : Base salary up to ~$225K, plus equity Environment : Pre-revenue biotech, lean team, high ownership Why This Role True Head of Quality ownership, not a layer under multiple levels Opportunity to build and shape systems, teams, and processes Direct visibility with executive leadership Positioned at a critical inflection point toward regulatory approval and commercialization #J-18808-Ljbffr