Computer System Validation (CSV) Manager/Senior Manager

Overview

The CSV manager is responsible for oversight of applicable computer system validations, authoring, reviewing and approving operational GxP SOPs, managing external service providers and interfacing with internal Process Owners to assure that application upgrades and enhancements are completed on time as well as meets all compliance requirements. Additional responsibilities include administration of Master Control, Veeva Vault, Argus, DocuSign Part 11, and TraceLink

Responsibilities

• Implement and validate Quality Management Systems, eTMF drug safety systems, electronic signatures, and EDMS systems, including but not limited to Master Control, Veeva, Argus, and DocuSign.
• Administer, implement, validate and test hosted GxP applications within the pharmaceutical, biomedical industries.
• Develop and maintain Test Plans, Validation Protocols, Validation Summary Reports, User Requirements, Administration SOPs and other related documents.
• Initiate, review and approve Change Requests.
• Provide guidance on CSV validation issues and discrepancies; and support investigation of CSV defects and quality records (deviations and CAPAs).
• Provide support to external and internal audits related to CSV activities.
• Maintain externally hosted GxP applications including SaaS applications in a validated state.
• Manage contract resources and Managed Service Providers with projects and ongoing validation needs.
• Author and revise validation documents such as SOPs, protocols and work instructions.
• Administer GxP and R&D systems.
• Assist as needed in audits and inspections.
• Contribute to projects related to QA CSV improvements and system reliability.
• Direct the IT process development team to establish and maintain IT SOPs, Work Instructions and related documents.
• Support the organization in the on-going Sarbanes Oxley computer controls, testing and audit processes.
• Partner with QA to manage systems validation, periodic reviews and vendor assessments.
• Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
• Other responsibilities are performed as assigned or needed.

Qualifications

• BS or equivalent experience in a life science and/or information systems technologies.
• For the manager level, the incumbent must have 5+ years of experience managing CSV in the pharmaceutical, biotechnology and/or medical device manufacturing equipment, automation, processes and facilities industries. The senior manager level will have 8+ years' experience.
• Experienced in gap analysis, remediation plans and corrective and preventive action (CAPA), in reviewing, modifying and writing standard operating procedures (SOPs).
• Must have hands on experience in qualifying production servers to meet regulatory requirements.
• Highly motivated and flexible; thrives in a fast-paced and changing environment; excellent interpersonal and team orientation skills to work effectively with managed service providers as well as partner with internal clients.
• Demonstrated knowledge of CSV, Electronic Records/Electronic Signatures, 21 CFR Part 11, 210, 211, 820. and Annex 11 principles in the biotechnology or pharmaceutical industry.
• Knowledge and expertise with Software as a Service (SaaS) systems, automated process equipment and clinical data management software in the biotechnology or pharmaceutical industry.
• Well-developed computer skills and fluent with Microsoft office applications.
• Must have the effectively balance technical expertise and understanding of the business to influence decision-making.
• Must have excellent project management skills.
• Proven ability to think critically, demonstrated troubleshooting and problem-solving skills and decision making.
• Ability to function efficiently and independently in a changing environment.
• Excellent verbal and written communication skills, including translating business needs into user requirements.

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