Executive Director, Site Quality Lead Greater Salt Lake City, UT Area

The Company is seeking an Executive Director & Site Quality Lead to join their team. The successful candidate will be a key member of the site leadership team, with a primary focus on building and leading the QA and QC teams to ensure the site is in a state of readiness for commercial product launch. This role is pivotal in fostering a culture of innovation, continuous improvement, and adherence to core values. The Executive Director will be responsible for overseeing GMP/GLP quality operations, including quality control laboratories, batch record reviews, and environmental monitoring. They will also be accountable for the site's overall compliance and inspection readiness, serving as a strategic partner in developing and maintaining site culture and long-term strategy. Applicants for this role at the company should have a BS in a scientific discipline, with an MS and professional certification in quality, compliance, and/or regulatory preferred, and at least 15 years' GMP experience in the pharmaceutical industry. A strong background in in-house manufacturing, QC testing, and CMC development is essential, with experience in large molecule or commercialization being a plus. The ideal candidate will have a current and strong working knowledge of relevant regulatory guidelines and experience in inspection management and health authority interactions. The role requires the ability to travel domestically and internationally and a proven track record in leading and developing teams.

Hiring Company

Denali Therapeutics