IT Compliance Manager

This position will be responsible for:Drafting, reviewing and approving local validation and compliance documents supporting GxP or SOX computerized systems and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation. Examples include: SOPs, qualification protocols, gap assessments, user requirements, functional and configuration specifications, validation plans, validation summary reports and change controls.Keeping current with regulatory developments, corporate requirements, system acquisitions, audit findings, CAPA responses and technical progress in computerized systems.Overseeing the execution of testing in support of change control to computerized systems including SOPs, scripts and reports.Supporting  IT in compliance and validation activities and will be a resource to the entire organization for input to computerized system use.Maintaining a pro-active perspective in generating, developing, assessing, identifying and communicating economically viable innovations in information technology with respect to compliance issues and maintains active, cross-functional approach (IT, QA, QC) to problem resolution.



Knowledge, Skills and Traits:Strong theoretical and practical knowledge of information systems in a regulated industry.Thorough understanding of GxP requirements, EU Annex 11 and 21 CFR Part 11 regulationsFamiliarity with GAMP and other approaches to System Development Life Cycles (SDLC).Demonstrated ability in development of validation protocols, direct supervision, statistical analysis, and technical investigations.Knowledge and experience relative to computer programming, relational databases, and process control.Experience in writing and executing validation documentation.Must be an effective communicator and have demonstrated project leadership abilities in a matrix environment.Excellent writing skillsAnalytical skills requiredExcellent verbal and written communication skills requiredStrong interpersonal skills and ability to communicate effectivelyAbility to multi-task and work on a variety of projects at one timeWorking knowledge of MS Office and MS Project

 

Educational Level: BS/BA degree in science (preferably chemistry/ microbiology) or BA/BS in Computer Science

 

Experience Level: 6-8 years of experience with regulatory compliance and implementation, validation, and maintenance of information systems in a GxP environment.