Senior Manager, Gxp It Quality Assurance
Current- Provided 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..
- 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.