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
FAQs
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