Head of Quality, Cell & Gene Therapy — Equity & Onsite

EPM Scientific; Salt Lake City (UT); On-site; USD 203,000 - 248,000; Full time

Benefits offered by this job

Equity participation

Onsite role

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Leadership

Quality Assurance

Quality Control

Microbiology

GMP compliance

Regulatory submissions

Cross-functional collaboration

Startup environment adaptation

Tools

eQMS

LIMS

Job description

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.