Quality Engineer

Denali Therapeutics • Salt Lake City, UT

5d

About The Position

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. We are seeking a detail-oriented and experienced Lead QA Associate to support biologics manufacturing operations. The Lead QA Associate primary focus will be on enhancing and maintaining the quality oversight and compliance systems for validation activities. Additionally, this individual is QA involved in supporting and coordinating day-to-day activities related to system and software validations, onboarding new equipment, and routine facility, utility and equipment calibration and maintenance programs.

Requirements

• 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.
• Familiar with Master Control, Blue Mountain and Kneat applications

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

Benefits

• Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees