Executive Director & Site Quality Head

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. Reporting to the Vice President of Quality, the Executive Director & Site Quality Head will be a member of the site leadership team and a hands‑on contributor to the continued build and evolution of Denali’s Clinical and Commercial manufacturing site in Utah.

Responsibilities

• Oversee GMP/GLP quality operations in Utah, including quality control laboratories/testing, batch record reviews and release, environmental monitoring, and external testing laboratories.
• Accountable for overall compliance and inspection readiness of the site for health‑authority inspections (PLI, general GMPs, etc.).
• Partner with the Utah site head to develop and maintain site culture, long‑term strategy, and inspection readiness.
• Build, supervise, develop, promote, hire, and train the GxP QC and QA team.
• Represent Quality on the Utah Site Leadership Team and Denali Quality Leadership Team.
• Establish and monitor site quality metrics and KPIs for performance monitoring and Quality System Management Reviews.
• Implement, maintain, and optimize quality systems including document control, change management, deviations, CAPAs, audits, and compliance initiatives.
• Support GMP site qualification, including review and approval of SOPs, work instructions, specifications, stability studies, method validations, test methods, and utility/equipment/room qualifications.
• Lead direct reports through annual goal setting, growth planning, adherence to company policies, training compliance, and provide ongoing feedback on development and improvement.

Qualifications

• BS in a scientific discipline (MS and professional certification in quality, compliance, or regulatory preferred).
• 15+ years of GMP experience in the pharmaceutical industry, including 12+ years of people‑leadership experience.
• Experience with in‑house manufacturing, QC testing, and CMC development.
• Large‑molecule or commercialization experience is a plus.
• Experience with inspection management, mock inspections, and health‑authority interactions.
• Strong working knowledge of 21 CFR 210‑211, Part 11, 610 & 820 cGMP/GLPs; EU cGMP/GLPs; and ICH quality and development guidelines.
• Familiarity with electronic QMS (eQMS) systems.
• Ability to travel domestically and internationally.

Benefits

• Competitive total rewards package.
• 401(k) retirement plan.
• Healthcare coverage.
• Employee Stock Purchase Plan (ESPP).
• Broad range of additional benefits.

Compensation for the role will depend on the candidate’s qualifications, skills, competencies, and experience.