Health Sciences IT (HSIT) is looking for a person to manage compliance and validation of various computer systems and processes. The HSIT Research team provides support for the six schools of the health sciences. The compliance and validation manager will be responsible for researching and understanding various governmental standards and security requirements such as NIST 800-171, Part 11 compliance, HIPAA, etc. and translating those standards to requirements for validation procedures for our systems as well as maintaining and updating documentation to maintain compliance. The incumbent will need to have a basic understanding of networks, firewalls, and server infrastructure to the level they can effectively communicate with server engineers and create appropriate documentation. Experience with HIPAA, FISMA, 21 CFR Part 11, or various NIST compliance and validation are required. The compliance and validation manager will handle writing/reviewing various policies and procedures, POA&M documents and SSPs. The incumbent will also validate systems as updates are completed by updating and expanding documentation as well as performing various systems tests to ensure the system is validated after updates. This person will also review/audit systems updating SSPs and other documentation as needed to comply with various security standards and policies. Audits on existing systems and review of user actions will also need to be completed on a regular basis. The compliance and validation manager will work closely with other team members such as system architects, IT security, web developers, and system engineers to create plans in which compliance with various standards can be achieved. The incumbent will work to ensure new templates or processes created for human subject research studies are compliant with federal requirements, for example 21 CFR Part 11. Meticulous attention to detail and excellent documentation skills are required.
Compliance and Validation Manager • Pittsburgh, PA, United States
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