| Computer System Validation Lead || Remote || 10+ Years || Rate 52 at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3427643&uid=626eec72fceb453d9c06d6852d4177e3 From: Pankaj, Thunderhawk [email protected] Reply to: [email protected] Computer System Validation Lead || Remote || 10+ Years || Rate 52 Any Special Requests : Candidate must possess global client exposure with a proven track record operating in a Global Delivery Model. Must have direct experience managing end-to-end technical compliance streams and securing client buy-in for critical validation milestones. Important Skill-Set, Technologies, Certifications, and Methodologies: Computer Systems Validation (CSV), 21 CFR Part 11, Good X Practice (GxP), Good Automated Manufacturing Practice 5 (GAMP 5), Sarbanes-Oxley Act Information Technology (SOX IT) Controls, Quality Management Systems (QMS), Document Management Systems, Change Management, Validation Deliverables, Process Validation, Primary Packaging Validation, Cleaning Validation, Revalidation Strategies, Validation Master Plan (VMP), Validation Schedule, Standard Operating Procedures (SOPs), Pharmaceutical Industry Testing Tools, Micro Focus Application Lifecycle Management (ALM), JIRA, Agile Methodologies, Regulatory Compliance, Stakeholder Engagement, Global Delivery Model. About the Role: We are seeking a highly meticulous Pharmaceutical IT Quality, Compliance & Validation Lead to spearhead the end-to-end quality assurance and regulatory enforcement of our life sciences technology portfolio. In this senior role, you will take full engineering ownership over validation deliverables, ensuring all automated software and physical packaging environments fully adhere to international regulatory standards. Operating within a high-visibility framework, you will establish operational templates, oversee global master validation schedules, and coordinate directly with cross-functional corporate stakeholders to deliver audit-ready, high-quality, and compliant software deployments. Key Responsibilities: Compliance Work-Stream Leadership: Lead end-to-end project compliance activities, ensuring all technology initiatives completely satisfy CSV, 21 CFR Part 11, GxP, GAMP 5, and SOX IT regulations. Validation Strategy Execution: Formulate and manage robust validation methodologies, covering process validation, primary packaging validation, cleaning validation, and routine revalidation strategies. Documentation & Governance: Establish localized system validation procedures, publish master verification blueprints, author specialized SOPs, and maintain the comprehensive overall board validation plan. Quality Management Monitoring: Implement, monitor, and enforce strict quality management systems to assure that active IT infrastructure projects meet stringent regulatory authority expectations. Stakeholder & Global Coordination: Engage daily with key client teams and international stakeholders to drive project execution, align priorities, and manage deliverable reporting. Testing Tool Oversight: Evaluate and execute specialized lifecycle test scenarios using industry-specific testing utilities, defect trackers, and data validation tools. Essential Skills: Life Sciences Regulatory Depth: Authoritative command over global pharma guidelines, specialized electronic record/signature regulations, and computer system qualification paths. Subject Matter Expertise: Deep structural experience across enterprise Quality Management, secure Document Management, and rigorous Change Management validation gates. Global Delivery Management: Demonstrated success governing technology compliance pipelines across distributed, multi-national onshore-offshore models. Desirable Skills: Lifecycle Platform Knowhow: Practical proficiency utilizing Application Lifecycle Management (ALM) platforms, JIRA, and Agile Methodologies to track and inspect system engineering deliverables. Keywords in your resume: Validation Lead, CSV, 21 CFR Part 11, GxP, GAMP 5, SOX IT, Quality Management, Change Management, Process Validation, Validation Master Plan, SOPs, Testing Tools, ALM, JIRA, Agile, Global Delivery. Keywords: information technology Computer System Validation Lead || Remote || 10+ Years || Rate 52 [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3427643&uid=626eec72fceb453d9c06d6852d4177e3 |
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| 09:13 PM 05-Jun-26 |