Lead, QCTS Data Integrity & Computerized Systems

Responsibilities

• 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
• Partner with QC labs leads, system owners, Validation, and IT to ensure robust lifecycle management of QC systems
• Lead implementation of change management for QC instruments, software upgrades, and new laboratory technologies
• Maintain and improve data integrity practices including data review workflows, audit trails, user access, and backup/restore procedures
• Support QC investigations (deviations, OOS/OOT, CAPAs) involving data integrity or system performance
• Lead authoring and maintenance of QCTS procedures, work instructions, and validation protocols
• Coordinate with external qualified service providers to ensure QC systems are validated
• Support internal and external audits/inspections as the QCTS Data Integrity SME
• Deliver training, guidance, and technical mentorship to QC analysts and system users

Requirements

• Degree in a science-related field
• 10+ years of experience in IT Systems/CSV, Enterprise Solutions (Veeva, CDS), QMS, and data integrity
• 10+ years of experience working in a Good Manufacturing Practices (GMP) environment
• Subject matter expertise in 21 CFR Part 11, GAMP 5, and EU Annex 11
• Subject matter expertise in Good Documentation Practices (GDP)
• Experience with Excel spreadsheet validation
• Prior experience working in a CDMO environment
• Excellent computer literacy (MS Word, Excel, SmartSheets)
• Excellent project management skills (MS Project, SmartSheets)
• Excellent executive communication skills

Benefits

• Paid vacation days based on tenure
• Paid sick time
• 10 observed holidays plus 2 floating holidays and 1 volunteer day
• 401(k) plan with company match up to 6%
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental and vision care
• Employer-paid basic term life/personal accident insurance

About the Company

Genezen provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials to meet the exacting needs of clients in the rapidly growing gene therapy field.