- Salt Lake City, Utah, United States
- 15+ years
Lead and manage quality operations at Denali’s Utah manufacturing site, ensuring GMP/GLP compliance and inspection readiness.
Compensation
Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.
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 the overall compliance and inspection readiness of the site in preparation for key health authority inspections.
- 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.
Requirements
- Bachelor's in a scientific discipline
- Master's in a scientific discipline (preferred)
- Professional certification in quality, compliance and/or regulatory (preferred)
- Nice to have: Large molecule or commercialization experience