Quality Control (QC) Systems & Equipment Administrator
Denali Therapeutics
Summary
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.
Job description
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.
Requirements
- Bachelor's degree in chemistry, biochemistry, engineering, or a related scientific or technical discipline
- 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
Benefits
- 401(k)
- Healthcare coverage
- ESPP
Company overview
Denali Therapeutics is a pioneering biotechnology company focused on developing innovative therapeutics for neurodegenerative and lysosomal storage diseases. Founded in 2015 and headquartered in South San Francisco, California, the company has developed a proprietary TransportVehicle™ (TV) platform designed to enable biotherapeutics to cross the blood-brain barrier, addressing one of the most significant challenges in treating central nervous system disorders. Denali's pipeline includes promising candidates for conditions such as Hunter syndrome (MPS II), Parkinson's disease, frontotemporal dementia, Sanfilippo syndrome (MPS IIIA), and MPS I, with several programs in advanced clinical development stages. The company collaborates with major pharmaceutical partners including Biogen and Sanofi, leveraging its platform technology to create a new class of barrier-crossing therapeutics. With approximately 500-1,000 employees and operations spanning multiple locations including Salt Lake City, Denali Therapeutics represents a leading force in neuroscience drug development, combining deep scientific expertise with a patient-centric approach to transform treatment paradigms for serious neurological conditions.