Denali Therapeutics · 8 hours ago
Quality Engineer
Salt Lake City, UT
Full-time
Onsite
Senior Level
5+ years expDenali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases. They are seeking a detail-oriented and experienced Lead QA Associate to support biologics manufacturing operations, focusing on enhancing and maintaining quality oversight and compliance systems for validation activities.
BiotechnologyGeneticsHealth DiagnosticsTherapeutics
Responsibilities
Review GMP validation documentation for Risk Assessment, System Classification, URS, IOQ, PQ protocols and reports and calibration and maintenance documentation
Collaborate cross-functionally—including Process Dev, QC, Manufacturing, and Validation—to support capital projects, scale‑up, tech transfer, and inspection readiness
Represent Quality for validation activities generated on the site or impactful to the site
Support computer system validation policies and overall strategies and ensure compliance and consistency with regulatory requirements and best industry practices
Provide quality input on the development of validation policies, procedures, standards and templates
Review and approve technical documents throughout the equipment/system lifecycle from commissioning, qualification and/or validation through decommissioning, including validation plans, risk assessments, test protocols and reports
Provide input into validation and testing strategies based on system risk, complexity, and other relevant factors and ensure all validated systems and documentation comply with applicable regulatory requirements
Support other Quality Operation activities such as on the floor presence, material disposition and deviation/capa management
Qualification
Required
Bachelor's degree in life science, biology, biotechnology, or a related scientific discipline
5+ years of experience in QA or QC within a biologics or pharmaceutical manufacturing environment
Previous experience working in a GMP regulated facility with focus on GMP validation activities such as generation, execution and approvals
Familiarity with different types of validation such as laboratory and manufacturing equipment, facility and utility cleanroom systems, validation documents, and vendor qualification and validation requirements
In depth understanding of cGMP, FDA, and EU regulatory requirements
Excellent communication, documentation, and organizational skills
Ability to work independently and collaborate effectively with cross-functional teams
Preferred
Familiar with Master Control, Blue Mountain and Kneat applications
Benefits
401k
Healthcare coverage
ESPP
A broad range of other benefits
Company
Denali Therapeutics
Denali Therapeutics is dedicated to defeating neurodegenerative diseases to deliver safe and effective medicines to patients and families.
501-1000 employees
H1B Sponsorship
Denali Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (14)
2023 (7)
2022 (6)
2021 (5)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.32BKey Investors
Royalty PharmaBaillie Gifford
2025-12-04Post Ipo Debt· $200M
2024-02-27Post Ipo Equity· $500M
2022-10-19Post Ipo Equity· $275M
Leadership Team
Ryan Watts
CEO
Peter Chin
Sr. Vice President & Head of Late-Stage Clinical Development and Medical Affairs
Recent News
2026-01-11
Longevity.Technology
2026-01-03
Company data provided by crunchbase