<p>The Position</p> <p>This position will work within the cGMP, GLP, and GCP-regulated Quality organization to provide validation and lifecycle support for computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced, and/or modified. The in cumbent will be responsible for guiding, generating, reviewing, and/or approving system assessments, test scripts, change controls, process improvements, and data integrity and governance at the applicable points of the system lifecycle. The position will serve as the subject matter expert to provide compliance leadership and oversight for CSV projects, collaborating with business partners to maintain and improve computer system validation processes.</p> <p>Responsibilities</p> <ul> <li>Provides Quality guidance for CSV efforts related to requirements engineering, system risk assessments, and data integrity assessments. </li><li>Reviews and approves validation documentation, including Validation Plans, Requirements Specifications, Risk Assessments, Functional Requirements Specifications, Testing Protocols, Requirements Trace Matrices, and Summary Reports </li><li>Serve as an SME for CSV and maintain knowledge and information in the Computer System Validation area of expertise </li><li>Review CSV documentation to ensure data integrity requirements are maintained </li><li>Review and approve discrepancies / deviations encountered during qualification / validation activities </li><li>Review, assess, and approve computerized system change controls </li><li>Coordinate validation activities with key stakeholders </li><li>Provide direction to validation contractors (if required) </li><li>Communicate CSV approach in support of audits </li><li>Prepare documentation and provide support for regulatory inspections and inspection readiness activities. </li><li>Review and approve periodic reviews of system validation. Ensure appropriate remediation plans are determined for gaps identified during periodic reviews. </li></ul> <p>Requirements:</p> <ul> <li>Bachelor's degree in an applicable science field. </li><li>Additional Quality related certification desired, CQA, CQMP </li><li>Minimum of 5 years of experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization with expanding responsibilities related to computerized system, equipment, and/or instrument qualification. </li><li>Working knowledge of overall GMP and/or GLP FDA, EU, and ICH regulations. </li></ul> <p>Preferred:</p> <ul> <li>Prior experience with use of an electronic document management system in a regulated environment. </li></ul>