Senior Director, Quality

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