Senior Manager CSV QA

Senior Manager

• CSV QA Location: Boston, MA (Hybrid) Client: wipro Job Description: We are seeking an experienced Senior Manager
• CSV QA to lead Computer System Validation (CSV) and Quality Assurance (QA) efforts in a regulated environment. The ideal candidate will have expertise in GxP, FDA 21 CFR Part 11, validation lifecycle, and compliance frameworks for software and IT systems used in the pharmaceutical, biotechnology, or medical device industry. Responsibilities: Develop, implement, and oversee CSV policies, procedures, and validation strategies to ensure regulatory compliance. Lead validation efforts for GxP systems, including ERP, LIMS, MES, QMS, and cloud-based applications. Ensure compliance with FDA 21 CFR Part 11, GAMP 5, ISO 13485, and other regulatory requirements. Manage the entire validation lifecycle (IQ, OQ, PQ) and risk-based testing for software applications. Collaborate with IT, QA, regulatory, and business stakeholders to maintain compliance and operational excellence. Perform and oversee gap analysis, risk assessments, audits, and change control processes. Lead and mentor a team of CSV professionals, providing guidance on best practices and industry standards. Maintain validation documentation, SOPs, and compliance reports for audits and regulatory inspections. Work in an Agile/SDLC environment to integrate CSV principles into DevOps workflows. Requirements: 10+ years of experience in CSV, QA, and regulatory compliance in life sciences, pharma, or biotech. Expertise in GxP, FDA regulations, and computerized system validation methodologies. Strong knowledge of ERP, LIMS, QMS, MES, or cloud-based GxP systems. Hands-on experience in CSV tools like ValGenesis, ComplianceWire, or HP ALM. Experience with data integrity, electronic records/e-signatures (ERES), and audit trail reviews. Strong leadership, problem-solving, and communication skills. CSV or Quality certifications (e.g., ASQ, PMP, GAMP, Six Sigma) are a plus.