IT Compliance and Validation Supervisor
Posted on Aug 7, 2020 by Renaissance LLC
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
The IT Compliance and Validation Supervisor is position is responsible for leading a team that is tasked with supporting the design, installation, implementation and validation of electronic systems to meet all applicable industry standards and regulatory requirements. The successful candidate will act as an advisor to the Director of IT in all areas of system compliance and validation and must have the ability to raise issues that they see as risk to the company. This position frequently interacts with customers and other groups at the Site and coordinates the IT validation tasks.
• Guides the work efforts of direct reports, and mentors them in all areas of compliance and validation.
• Responsible for initiating/maintaining the IT Master Inventory of Electronic Systems.
• Prepare gap assessments, user requirements, functional and configuration specifications, traceability matrix, test scripts, validation plans, IQ, OQ, PQ and summary reports. Other validation documentation as needed.
• Gather, understand and document business objective.
• Coordination of testing activities within the team, report progress of testing and significance of unfavorable results.
• 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 IT leadership and business units to enhance existing procedures to further the efficiencies of compliance execution.
• Other tasks as assigned.
Bachelor's degree or Associates Degree in Computer Science, Chemistry, Engineering or similar degree required, along with related business experience and a proven record of achievement. A minimum of 5 years of relevant experience in the pharmaceutical industry is required, including at least 2 years' experience supporting compliant IT systems. Must have a strong understanding of 21 CFR Part 11 code. Must be able speak to all levels of the organization regarding questions or concerns around compliance issues.