Executive Director & Site Quality Lead

Scorpion Therapeutics; Salt Lake City (UT); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Scorpion Therapeutics seeks a senior QA/QC leader in Utah to oversee GMP/GLP quality operations across QC labs, batch release, and environmental monitoring. You will drive compliance, audit readiness, and quality improvements on site with cross‑functional partners.

The role requires deep GMP experience, 12+ years in leadership, and strong regulatory knowledge to support both domestic and international inspections and initiatives.

Qualifications

• BS in a scientific discipline; MS and quality/compliance/regulatory certification preferred.
• 15+ years GMP pharmaceutical experience, including 12+ years people leadership.

Responsibilities

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

Skills

GMP pharmaceutical experience

People leadership

Inspection management

21 CFR knowledge

eQMS familiarity

Regulatory compliance

Education

BS in scientific discipline

MS degree preferred

Regulatory certification preferred

Tools

eQMS

Job description

Key Accountabilities/Core Job Responsibilities

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

Qualifications/Skills

• BS in a scientific discipline (MS and quality/compliance/regulatory certification preferred); 15+ years GMP pharmaceutical experience, including 12+ years people leadership.
• Experience with in-house manufacturing, QC testing, and CMC development.
• Large molecule/commercialization experience (plus).
• Inspection management, mock inspections, Health Authority interactions.
• Strong knowledge of 21 CFR 210-211, Part 11, 610 & 820; EU cGMP/GLPs; ICH quality/guidelines.
• Familiarity with eQMS systems.
• Domestic and international travel.

Benefits

• Competitive total rewards package including 401k, healthcare coverage, and ESPP.