Do you have IT Governance experience within biotech, helping define, implement, and document Change Controls?
Our biotech client is standing up SOX and GxP-related IT governance controls in preparation for FDA submission. We are seeking an IT Governance & Controls Specialist to help operationalize newly formed SOX and GxP policies by creating change control documentation within their change management system (ServiceNow). Working with business leads and Quality, you will leverage your IT governance and business systems skills to facilitate and participate in the implementation of relevant IT governance controls. For new systems you will ensure adherence to internal policies by performing risk analysis, reviewing change requests, writing and executing tests, and overseeing validation activities.
Critical Success Factors
- Experience managing IT Compliance and Governance in biotech and/or pharma, working with regulated systems (SOX and GxP)
- Experience implementing compliance related controls into business systems and knowledge of levels of acceptable risk while implementing a Compliance Program
- Experience working on change requests, following Change Control processes, ideally within ServiceNow
Job ID: 2008-5914
SQA Group is an equal opportunity employer and supports workforce diversity.