Lead, QCTS Data Integrity & Computerized Systems

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.  WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The Lead, Quality Control Technical Services (QCTS) – Data Integrity is responsible for ensuring that QC laboratory systems, instruments, software, and associated data workflows meet regulatory expectations for data integrity and GxP compliance. This role provides expert oversight and support across QC laboratory for computerized system implementation, instrument qualification, assay data workflows, software validation, and data governance activities. The lead partners closely with QC operations, Validation, IT, and system owners to ensure that QC systems are designed and maintained, and monitored in alignment with 21 CFR Part 11 and EU Annex 11, ALCOA+ principles, and corporate data integrity standards.  The role supports audits and inspections, authors technical documentation, resolves data-related issues, and contributes leadership through scientific and systems expertise. ESSENTIAL JOB FUNCTIONS  Serve as the QCTS Data Integrity and Computerized System Validation SME, ensuring QC laboratory systems comply with 21 CFR part 11, EU Annex 11 and internal DI policies.  Provide expertise and support for QC computerized systems, including instrument software, standalone analytical instruments, and data acquisition/processing tools, including Excel spreadsheets. Partner with QC labs leads, system owners, Validation, and IT to ensure robust lifecycle management of QC systems, including system qualification, validation, periodic review, and configuration controls. Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment. Lead implementation of change management of QC instruments, software upgrades, and new laboratory technologies to ensure readiness for GMP use. Maintain and improve data integrity practices within the QC function, including data review workflows, audit trails, user access, data storage, and backup/restore procedures. Support QC investigations (deviations, OOS/OOT, CAPAs) involving...