Reporting to the Vice President of Quality, the Executive Director & Site Quality Lead will be a member of the site leadership team, and a successful hands-on contributor to the continued build and evolution of Denali's Clinical and Commercial manufacturing site in Utah. This individual will be accountable for building and leading the QA and QC teams in Utah and ensuring the site is in an inspection-ready state for anticipated commercial product launch. This leader will foster an environment that encourages Denali's Core Values, innovation, and continuous improvement.
Key Accountabilities/Core Job 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 (PLI, general GMPs, etc.)
- Key strategic partner to the Utah site head in developing and maintaining site culture, long term strategy and inspection readiness
- Responsible for building, supervising, developing, promoting, hiring and training for 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 site 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 and equipment/room qualifications.
- Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
Qualifications/Skills: - Typically requires a BS in a scientific discipline (with an MS and professional certification in quality, compliance and/or regulatory preferred) and 15+ years of GMP experience in the Pharmaceutical industry, to include 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
- Current and 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 eQMS systems.
- Able to travel domestically and internationally.
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. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.
