Copy of Quality & Compliance Manager, Computer System Validation

About Our Client:The organization operates within the regulated life sciences sector, focusing on clinical research and laboratory operations. It addresses the challenge of ensuring computerized systems comply with GxP standards, maintain data integrity, and remain inspection-ready throughout their lifecycle. The organization achieves this by implementing risk-based quality assurance and continuous improvement practices across clinical and laboratory environments. About the Opportunity:The QUALITY & COMPLIANCE MANAGER, COMPUTER SYSTEM VALIDATION is responsible for overseeing the quality and validation of GxP computerized systems supporting clinical research and laboratory activities. This role ensures systems are fit for intended use, compliant with regulatory requirements, and maintain data integrity from implementation to retirement. The position contributes by establishing consistent validation practices and driving continuous improvement, thereby supporting the organization's compliance and operational effectiveness. Responsibilities:Provide independent, risk-based Quality Assurance oversight of GxP computerized systems throughout their lifecycle.Review and approve validation and assurance deliverables, including risk assessments, validation plans, test evidence, and release-readiness documentation.Ensure computerized systems comply with internal procedures, client commitments, and regulatory requirements.Oversee QA for systems supporting clinical platforms, laboratory information systems, electronic laboratory notebooks, chromatography data systems, and related software.Manage evaluation of system changes, incidents, deviations, CAPAs, upgrades, data migrations, periodic reviews, and decommissioning.Support qualification and oversight of software, cloud, data, and computerized-system service providers.Develop and improve policies, procedures, templates, tools, and training for system validation and software assurance.Prepare for and support audits and inspections involving computerized systems.Establish and report metrics related to validation status, compliance, deviations, CAPAs, supplier performance, and risks. Requirements:Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or a related scientific or technical discipline.Minimum of six years of progressively responsible experience in Quality Assurance, computer system validation, or related disciplines within regulated life sciences.Experience providing independent QA oversight of GxP computerized systems throughout the lifecycle.Proficient in reviewing and approving validation documentation such as plans, risk assessments, test plans, and deviation records.Knowledge of FDA electronic record and signature requirements, EU Annex 11, ICH GCP, GLP, and data integrity principles.Experience with computerized systems used in CRO, clinical research, or laboratory operations.Familiarity with risk-based validation approaches for various software and platforms.Experience supporting supplier qualification, vendor audits, sponsor audits, and regulatory inspections.Ability to collaborate effectively with diverse stakeholders in a matrixed, geographically dispersed environment. Pay Range and Compensation Package:The pay range and compensation package for this role will be determined based on the candidate's experience, skills, and other relevant factors. Equal Opportunity Statement: Our client is an equal opportunity employer. They celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, or national origin. Note:RemoteHunter is a recruitment partner of this role. Please note that all employment decisions, including candidate assessment, interviews, hiring, compensation, and employment terms, are made exclusively by the hiring employer.