Manager, CSV

1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. JOB DESCRIPTION The Manager, Global CSV provides expertise, guidance, and leadership for the global validation and software assurance strategy and efforts to implement and support Global IT-based systems for use in Cellectis facilities. The primary responsibility of this role is to develop strategies and plans to transform, execute, and sustain the Global Validation program with a risk-based approach. This includes creating Global Validation and Software Assurance procedures and processes to support GMP activities and ensuring the adoption of these procedures. This is a hands-on role that involves both strategic planning and execution. Position Responsibilities Develop and manage CSV lifecycle documentation: Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, and Summary Reports. Ensure validation activities meet FDA, EMA, and other global regulatory standards. Identify and support the resolution of deviations noted during protocol execution; participate in resolving departmental deviations. Lead validation efforts for systems such as eQMS, EMS, ERP (Oracle), and other GMP-critical platforms. Author, revise, and maintain Validation Master Plans for Global Computerized Systems. Validate integration points between automation systems and enterprise platforms (e.g., MES to ERP, MES to LIMS). Computer Software Assurance (CSA) Conduct risk assessments to determine validation rigor based on system impact and complexity. Implement CSA principles to streamline validation of low-risk systems while maintaining compliance. Promote CSA methodologies to reduce documentation burden and enhance testing efficiency, ensuring robust, efficient, and compliant processes. Quality & Regulatory Compliance Ensure systems comply with 21 CFR Part 11, EU Annex 11, GAMP 5, and internal SOPs. Lead investigations and CAPAs related to system failures or deviations. Support regulatory audits by providing validation documentation and system evidence. Project & Team Management Coordinate validation schedules, resource allocation, and project timelines. Manage cross-functional teams including QA, IT, automation engineers, and business users. Train and mentor staff on CSV, CSA, and automation compliance best practices. Documentation & Change Control Maintain accurate documentation for all validated systems. Review and approve change control requests impacting validated systems. Continuous Improvement Lead initiatives to enhance validation efficiency and system reliability. Monitor system performance and validation metrics for improvements. Additional Requirements Travel up to 10% of the time. Education and Experience Bachelors degree in a technical/science/mathematical field required. 5-8 years validation experience in biotech/pharmaceutical environment. At least 1 year managing validation functions. Experience with SaaS, IaaS, PaaS software implementations. Experience with enterprise systems like CRM, LMS, ERP, LIMS, ELN. Proficiency in writing and executing test scripts. Previous leadership experience required. Technical Skills and Core Competencies Deep understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and CSA approaches. Knowledge of system integration, data integrity, cybersecurity, risk management, and testing. Strong project and change management skills. Excellent technical writing and audit readiness skills. Physical Position Requirements Sit/stand for long periods, operate office machinery, occasionally lift up to 20 pounds.

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