Pay or shift range: $90,900 USD to $98,700 USD The estimated range is the budgeted amount for this position. Final offers are based on various factors, including skill set, experience, location, qualifications and other job-related reasons. Description Guides the work efforts of consultants and other team members, and mentors them in all areas of computer system compliance and validation. Develop and implement CSV and Data Integrity processes to ensure compliance with GxP, GAMP, OECD, and applicable regulations in conjunction with the operations counterpart. Responsible for providing input for maintaining the IT Master Inventory of Electronic Systems. Lead CSV projects, provide guidance to the business users and contractors/vendors. Coordinates, performs, and assists in the development of computerized system life cycle documentation and tasks to establish computerized systems that meet requirements. Perform various assessments (gap analysis, 21 CFR Part 11 assessment, GxP assessment, and Risk assessment), prepare user requirements, functional and configuration specifications, traceability matrix, test scripts, validation and data migration plans, IQ, OQ, PQ, and summary reports. Other validation documentation as needed. Be able to author, update/revise SOP and other documents, as needed. Assisting with issues, bugs, and deviations, adequate processing, and documentation. Gather, understand, and document business objectives. Coordination of testing activities within the team, reporting progress of testing, and the significance of unfavorable results. Perform periodic compliance assessments to maintain data integrity at the site. Create, support, and provide input into system administration and standard operating procedures (SOPs) to ensure adequate controls for maintaining the validated state. Coordinate and execute the training of Subject Matter Experts of electronic systems. Make recommendations for improvements in laboratory productivity and quality of data. Initiate and implement change control activities in accordance with current procedures. Work with MS&T leadership, IT leadership, and business units to enhance existing procedures to further the efficiencies of compliance execution. Participate in quality and process improvement initiatives and project teams. Contributes to the overall operations and to the achievements of department goals. Interact frequently with laboratory/manufacturing/IT/Quality facility staff to provide expertise on equipment/software validations. Address conditions/practices with appropriate personnel, report findings to QA and Operations Management. Qualifications Experience Required Must be able to speak to all levels of the organization regarding questions or concerns around compliance issues. Experience / Knowledge of 21 CFR Part 11, GAMP, CSV, and CSA. Knowledge of cGMP/GLP and 210, 211, 820 requirements. Bachelor’s degree in Science, Engineering, or related field, along with related business experience and a proven record of achievement. A minimum of 10 years of relevant Experience in the pharmaceutical industry is required, including at least 5 years’ Experience supporting compliant IT systems. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr Renaissance Pharma Inc.
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