Senior Manager, Gxp It Quality Assurance
CurrentProvided quality assurance & regulatory compliance oversight across software development and validation lifecycle activities of regulated computerized systems to ensure conformance to cGxPs, guidance & standards (i.e. 21 CFR Part 11, GAMP 5, Data Integrity) and internal SDLC requirements.Provided input, review and approval as Regulatory Compliance SME of key computer system validation life cycle deliverables including: Regulatory Risk Assessments, Validation Plans, and Requirements Specifications.Provided oversight of key software development life cycle (SDLC) processes such as problem, incident, change, release, & deviations. Maintained presence as the primary QA contact for the Problem Management team and supported over 20 problem investigations annually.Provided support during regulatory agency and third party inspections.Performed e-Signature Assessments of research partners to ensure compliance of clinical systems (e.g. Florence eBinders, DocuSign, Complion) with applicable ERES regulations.Conducted audits of external service providers as Regulatory Compliance SME.Provided quality oversight of new GAMP 5 Infrastructure Qualification initiative, including Risk Assessment and Qualification Plan approvals.Provided quality review of new regulatory guidance documents to recommend updated controls and procedures to ensure continued compliance with evolving regulatory landscape.Provided critical process improvements including:•Fostered a first-time-right approach by actively collaborating with stakeholders from project inception through approvals•Provided timely support; maintained a QA turn-around metric of not more than three business days•Implementation of new Digital Signature process, including requirements for Digital Certificate Risk Assessment.
