Genezen
Lead, QCTS Data Integrity & Computerized Systems
Lexington, MA
Sponsorship not specifiedDetected 34 days ago
ExcelClinical TrialsGMPCRISPRLeadershipGxP
About the role
- 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.
- Responsible for overall lifecycle management of computer system validation activities in QC/GMP environment.
- Coordinate with external qualified service providers to ensure <span data-ccp-par
Responsibilities
- 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 data integrity, system performance, or data workflow failures; provide technical root-cause contributions.
Company info
- 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.
- 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.
Apply directly at Genezen →Create a free account for alerts like thisView Genezen immigration profile
This listing is sourced directly from Genezen's careers page and normalized into a canonical job model.