Manager, CSV Cell Therapy
Core
Manager leading equipment and computerized system qualification, validation, and lifecycle management for CSV (Computerized Systems Validation) in cell therapy manufacturing and laboratory environments.
Role type
Manager, CSV Cell Therapy
Builds
Qualified and validated manufacturing and laboratory equipment, computerized systems, and validation documentation for cell therapy production.
Domain
Biopharmaceuticals / Cell Therapy / GxP Compliance
Required skills
cGXP requirements, 21 CFR Part 11 compliance, SDLC principles, equipment qualification, validation protocols, deviation/CAPA investigation, vendor management, project management, training delivery, regulatory audit support
Preferred skills
Pharmaceutical laboratory and manufacturing systems knowledge, User/Functional Requirements documentation, standardization of validation deliverables
Technologies
Computerized Systems, Validation Tools, Quality Management Systems
Responsibilities
Support equipment qualification and validation activities; Investigate and resolve Deviations and CAPA; Configure and document computerized systems for 21 CFR Part 11 compliance; Supervise vendors for qualification functions; Develop validation deliverables (Plans, Protocols, Reports); Manage projects of moderate scope; Author quality procedures and training documents; Provide technical support and guidance on validation and equipment issues; Act as SME in internal and regulatory audits.
Seniority
Manager, hands-on leadership