CSV QA Lead

Hello, We are looking for an experienced CSV QA Lead with strong expertise in Computer System Validation (CSV), GxP compliance, infrastructure qualification, and tool validation within the medical devices or biotechnology industry. The ideal candidate should have experience leading GxP infrastructure qualification, large-scale migration projects, and business separation/demerger-related CSV activities. Job Details Visa: USC/GCJob Title: CSV QA LeadLocation: Raritan, New JerseyWork Mode: HybridPay rate: $53-54/hr w2Experience: 8-10 Years Job Summary We are seeking a senior CSV consultant with expert knowledge of GxP regulations and Computer System Validation. The candidate will support infrastructure qualification, tool validation, and ongoing validation projects in the medical devices/biotechnology space. The role requires strong experience authoring and reviewing CSV validation deliverables, providing quality oversight, and ensuring compliant operation of supported GxP systems. Mandatory Skills & Experience 8-10 years of experience in medical devices or biotechnology, with direct Computer System Validation (CSV) experience.Practical knowledge of GxP regulations and standards, including:21 CFR Part 1121 CFR Part 210/211GAMP 5EU Annex 11Security and privacy requirementsExperience leading GxP infrastructure qualification and quality oversight of on-premises or cloud environments.Working knowledge of networks, databases, virtualization, ITIL processes, disaster recovery, and infrastructure security controls.Experience with Jira/Xray, qTest, or equivalent ALM/testing platforms.Strong knowledge of Computer System Validation and GxP compliance.Experience with business separation and demerger-related CSV activities.Infrastructure qualification and large-scale migration project experience. Key Responsibilities Author and review CSV validation deliverables.Prepare and review Compliance Plans, User Stories, Testing documentation, Traceability Matrices, and SDLC lifecycle deliverables.Lead GxP infrastructure qualification activities.Provide quality oversight for on-premises and cloud infrastructure environments.Ensure compliance with CFR Part 11 regulations and Quality Management Regulations.Work with SDLC tools such as Jira, ALM, qTest, and Xray.Support infrastructure qualification, tool validation, and ongoing validation projects.Guide business partners on GxP policies, procedures, and regulatory requirements.Coordinate with technology partners to ensure compliant working and operation of supported GxP systems.Independently lead discussions and meetings with business stakeholders.Proactively manage validation activities and ensure project deliverables meet quality and compliance expectations. Additional Requirements Excellent communication and stakeholder management skills.Ability to work proactively and independently.Strong capability to lead business discussions and guide teams on GxP policies and regulations.Ability to work in a fast-paced validation project environment.