CSV System Assurance Lead

Job Title: CSV/GxP System Assurance Lead

Location: King of Prussia, PA (Day-1 Onsite)

Visa: No H1-B, OPT, CPT.

Skills: CSV, CSA, GxP, FDA Compliance, GAMP, IQ/OQ/PQ, Risk Assessments, Change Management, Veeva, Argus, SAP Systems, MES, Serialization Systems, ALM, DMS, JIRA, Agile, Waterfall, Test Management, Validation Documentation, RTM, US-DSCSA

Requirements

• 10+ years of experience in CSV and GxP validation for Life Sciences applications.
• Hands-on experience validating SAP Systems, MES, Serialization systems, Veeva, and Argus.
• Strong understanding of Agile and Waterfall-based validation processes.
• Experience with ALM, DMS, and JIRA.
• Excellent communication, documentation, and stakeholder management skills.

Key Responsibilities

• Lead CSV and CSA activities for GxP applications including SAP, MES, Serialization, Veeva, and Argus.
• Perform GxP risk assessments, change management, and compliance checks across applications.
• Review requirement specifications, functional specs, user stories, acceptance criteria, and ensure test script completeness with full traceability.
• Conduct pre- and post-execution test protocol reviews to validate accuracy, completeness, and evidence quality.
• Ensure all validation deliverables Validation Plan, Validation Summary Report, RTM, and SOPs are accurately prepared.
• Manage defects using JIRA and guide the team on defect lifecycle and resolution.
• Handle change requests, including impact assessment, test plan creation, execution results, and defect tracking.
• Act as a single point of contact for system assurance, validation, and test management for regional business teams.
• Ensure service quality, customer satisfaction, and strong stakeholder engagement.
• Review system assurance deliverables and provide daily guidance to the team.
• (Good to have) Experience in US-DSCSA implementations.

Thanks & Regards, John Wilson
+1 2..1..0.. 9..3..9..5..1..6..4