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Csv Manager

The CSV Manager will play a critical role in bridging the gap between technical operations and IT functions, ensuring seamless collaboration and communication across cross-functional teams. This individual will be responsible for overseeing Computer System Validation (CSV) activities, ensuring compliance with regulatory requirements and internal quality standards. Acting as the Quality Assurance (QA) Subject Matter Expert (SME) for the CSV system, the manager will provide strategic guidance, technical expertise, and hands-on support throughout the validation lifecycle, including planning, execution, documentation, and audit readiness.

Responsibilities:

• Review and approve validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation.
• Provide support for SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.
• Ensure that all validation deliverables are met such as protocol execution, documentation of results, deviations, and corrective actions, and preparation of Summary Reports, Trace Matrices and Summary Reports associated with validated computer systems, as applicable. Ensure regulations, such as 21 CPR Part 11, 820, Annex 11 and cGMP, are addressed in validation
• Perform Risk Assessments of the CSV systems with an understanding of applying risk management principles.
• Review and approve periodic reviews and ongoing support of validated systems post Go-Live. Assist validation activities of cross-functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering.
• Assess the impact of system changes through change management and change control systems; participate in the planning and implementation of change. Review and approval of the change control related activities. Ensure that revalidation deliverables are met.
• Develop and maintain Validation SOPs, forms, documentation, and files. Provide training to colleagues and contractors on systems implementation and validation SOPs.
• Ensure Data Integrity Assessments is completed and Remediation Plans for the identified gap, if any, is developed with an understanding of applying ALCOA+ principles. Review, and approve completed assessment and ensure identified remediation, if any, are implemented in the approved period.

Qualifications:

• Ten plus (10+) years of relevant CSV, validation, within a cGMP environment
• Experience in the biotechnology and/medical or pharmaceutical industry required.
• Excellent written and verbal communication, Ability to work in a demanding environment.
• Collaborative with independent work skills and a strong work ethic
• Microsoft Office and management skills.
• Minimum of a B.S. in a Life Sciences discipline
• +5 years of management/subject matter expert experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry
• +5 years experience in Quality Assurance/Quality Control function including knowledge and application of COMP principles and working in FDA-regulated environment