Manager/Sr. Manager, Validation - CSV & Data Integrity
Genezenlabs · Lexington, MA
About this role
**Manager/Sr. Manager, Validation - CSV & Data Integrity** **About Genezen** Genezen is a rapidly growing gene therapy company providing process development, GMP viral vector production, and cell transduction services for gene and cell therapy clinical trials. We're committed to empowering innovative, collaborative problem solvers in a rewarding work environment. **Job Summary** Ensure computerized systems supporting GxP operations are appropriately assessed, validated, implemented, controlled, and maintained throughout their lifecycle. Manage qualification of GxP systems for laboratory and manufacturing equipment, as well as GxP software applications. Support the Data Integrity program to ensure GxP data is reliable, complete, accurate, attributable, and secure in accordance with regulatory expectations. **Key Responsibilities** **Computer Systems Validation** • Manage CSV strategy, governance framework, and risk-based validation approaches • Establish validation standards, templates, procedures, and best practices • Provide CSV leadership for implementations, upgrades, patches, configuration changes, integrations, data migrations, and system replacements • Oversee validation deliverables (Validation Plans, URS, Risk Assessments, IQ/OQ/PQ Protocols, etc.) • Manage multiple concurrent validation projects and dependencies • Execute periodic reviews and validation status activities **Data Integrity** • Support GxP data protection controls throughout data lifecycle • Serve as SME for ALCOA+ and data lifecycle management • Establish risk-based approaches for identifying and mitigating data integrity risks • Support audit trail reviews and data integrity assessments • Partner with QA, IT, and business process owners to address vulnerabilities **Leadership** • Mentor CSV professionals and cross-functional teams • Promote culture of data ownership and accountability • Establish CSV KPIs and quality metrics • Monitor regulatory trends and ensure program alignment • Lead CSV aspects of deviations, investigations, CAPAs, and change controls • Represent CSV during audits and regulatory inspections **Requirements** **Education** • Bachelor's degree in Engineering, Computer Science, or related discipline (Essential) **Experience** • 10+ years of Computer System Validation experience (Essential) • Hands-on CSV experience with implementations, upgrades, patches, configuration changes, integrations, data migrations, and system replacements (Essential) • Strong cross-functional collaboration with QA, QC, Manufacturing, Engineering, IT, and Operations (Essential) **Skills & Competencies** • Excellent communication skills (interpersonal, presentation, verbal, written) • Excellent technical writing and project management skills • Strong analytical problem-solving abilities • Proficiency in Microsoft Office (Word, Excel, Visio) and Adobe Acrobat • Strong knowledge of GxP regulations (21 CFR Parts 11, 210/211, EU GMP Annex 11, ICH guidelines, GAMP 5) • Ability to work in matrix-style, growing, safety-focused organizations **Compensation** • Manager: $130,000–$150,000 • Sr. Manager: $150,000–$170,000 **Special Requirements** • Criminal background check required • Adaptability for schedule changes based on business needs • Regular sitting for extended periods
Listing freshness
CronJobs last confirmed this listing 17h ago. If its source stops confirming the opening for seven days, this page is removed from active inventory.