Quality Control (Qc) Systems & Equipment Administrator

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

The QC Systems and Equipment Administrator owns the qualified state of Quality Control laboratory instruments and the validated state of QC computerized systems (Waters Empower, LabWare LIMS, ProteinSimple Compass, SciEx 32 Karat, Revvity ViPER, Agilent OpenLab, Molecular Devices SoftMax pro, and associated instrument software). The role is the single QC point of accountability for equipment lifecycle, qualification, calibration and preventive-maintenance scheduling, return-to-service, application administration, and the quality-system records (change controls, deviations, CAPAs, SOPs) that govern them.

The incumbent works directly with Engineering, IT, Quality Assurance, Validation, Procurement, and external vendors to keep instruments in service and systems inspection-ready, and drives improvements to LabWare and Empower workflows.

To preserve independence between system administration and record generation (FDA, Data Integrity and Compliance With Drug CGMP: Questions and Answers, Q&A 4), this role does not generate or review GMP release or stability test records in the systems it administers.

Key Responsibilities

• Manage the QC equipment lifecycle, including procurement, installation, qualification (IQ/OQ/PQ), routine use, relocation, and decommissioning.
• Maintain calibration and preventive maintenance schedules, records, and compliance with applicable 21 CFR requirements; coordinate servicing, repairs, OOT investigations, and return-to-service activities.
• Author and execute equipment qualification and requalification protocols, assess equipment reliability, and recommend repair or replacement.
• Administer QC computerized systems, including Empower, LabWare, Compass, 32 Karat, ViPR, OpenLab, and SoftMax Pro, in partnership with IT.
• Manage user access, roles, privileges, periodic access reviews, system configurations, and master data under change control.
• Oversee system backups, archives, recovery testing, audit trail reviews, periodic system reviews, and computerized system validation (CSV) documentation.
• Provide system support and training, and drive system enhancements, workflow automation, LIMS integration, and reporting improvements.
• Own change controls, deviations, CAPAs, risk assessments, and effectiveness checks related to QC equipment and computerized systems.
• Develop and maintain SOPs, work instructions, and forms; serve as QC subject-matter expert during audits and regulatory inspections.
• Monitor compliance metrics and partner with Engineering, Validation, and IT on equipment reliability, capital planning, vendor management, and continuous improvement.

Required Qualifications

• Typically requires a Bachelor's degree in chemistry, biochemistry, engineering, or a related scientific or technical discipline and 7+ years of experience in a GMP-regulated laboratory environment supporting analytical instruments and/or laboratory computerized systems (or MS with 4 years).
• Hands-on experience qualifying analytical instruments (e.g., HPLC/UPLC, icIEF/CE, spectrophotometers, balances, pH and osmolality meters) and authoring IQ/OQ/PQ documentation.
• Hands-on administration of at least one GMP laboratory computerized system (e.g., Waters Empower CDS, LabWare LIMS, ProteinSimple Compass).
• Working knowledge of 21 CFR Parts 11 and 211, FDA data integrity expectations, GAMP 5, and USP .
• Experience owning change controls, deviations, and CAPAs in an electronic quality management system.
• Ability to meet laboratory physical requirements, including specialized gowning, lifting and manipulating items greater than 25 lbs, climbing ladders, and standing for extended periods.

Preferred Qualifications

• LabWare LIMS configuration and administration experience.
• Empower administration experience (projects, users, privileges, custom fields, system policies).
• Exposure to EU GMP Annex 11 and Annex 15.
• Experience serving as an equipment or systems SME during regulatory inspections.

Competencies

• Technical writing to GMP documentation standards.
• Structured troubleshooting and root-cause analysis.
• Prioritization across competing instrument and system demands.
• Clear communication with analysts, QA, IT, Engineering, and vendors.

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.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

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