Senior Director, Quality

EPM Scientific; Salt Lake City (UT); Presencial; USD 203.000 - 248.000; Tempo integral

Benefícios oferecidos por esta vaga

Equity participation

Onsite role

Resumo da vaga

EPM Scientific is seeking a Senior Director of Quality in Salt Lake City, onsite, with end-to-end ownership of QA, QC and Microbiology. You will shape quality strategy and scale a lean team as the company transitions from clinical to commercial, ensuring readiness for regulatory submissions and inspections.

You will partner with executive leadership and cross-functional teams to build robust QMS, drive inspection readiness, and support BLA submissions.

Qualificações

• Lead and oversee QA, QC, and Microbiology functions.
• Own and enhance a GMP-compliant Quality Management System (QMS).
• Drive inspection readiness with regulatory interactions (FDA, global authorities).
• Oversee batch record review, release, and manufacturing quality.

Responsabilidades

• Lead QA, QC, and Microbiology teams.
• Maintain and optimize the QMS to meet GMP standards.
• Support regulatory submissions and inspection readiness (PAI/BLA).
• Collaborate with Manufacturing, CMC, and Technical Operations.
• Mentor and scale the Quality organization.
• Implement/evaluate systems like eQMS and LIMS.

Conhecimentos

Leadership

Quality Assurance

Quality Control

Microbiology

GMP compliance

Regulatory submissions

Cross-functional collaboration

Startup environment adaptation

Ferramentas

eQMS

LIMS

Descrição da vaga

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