Managed the creation, review and approval of eTMF GxP validation deliverables for all general releases and hotfixes, resulting in the completion of the validation package used by 30+ eTMF customers to reduce their validation and user acceptance testing timelines.• Collaborated with cross-functional teams to plan for and develop the validation deliverables to document the ongoing validation of the system, including: + change control requests, change control summaries, test plans, test summaries + user acceptance test cases with an associated risk-based analysis tool + trace matrices mapping eTMF functional requirements to user requirements + trace matrices mapping 21 CFR Part 11 and EU Annex 11 to eTMF requirements. • Proactively held weekly touchpoints with the Quality Assurance team to discuss the validation scope and deliverables for all product releases.• Collaborated with the Product Owners to create user requirements, ensuring that the user requirements were well defined, testable and compliant with work instructions.• Managed the user acceptance testing effort, including reviewing the output of all formal test runs, incidents and defects. + Worked with the Product Management and Engineering teams to triage and prioritize all defects found during UAT. + Created the test summary report, assembled the UAT package and delivered it to clients. + Answered client questions regarding the UAT package.• Performed document compliance reviews, editing the documents as necessary before sending on review and approval workflows. • Represented the eTMF Product Management team in client audits. Received good reviews from the internal Quality Assurance team and from clients for being well prepared for the audits.• Configured the internal eTMF production instance used for electronic review/approval of quality and validation deliverables, adding document types, workflows, users and groups.

• Directed the UAT effort for multiple products simultaneously, managing a team of 10 resources. • Served as the Subject Matter Expert (SME) for the eREG application, providing production support to Engineering, Software Testing and Application Support. • Created detailed eREG and eTMF functional requirements. Reviewed functional test scripts authored by the software test team and ensured requirements were traced to the correct test scripts and requirements were satisfied by the test scripts.• Managed the user acceptance test effort by collaborating with the Product Management team to author, review and approve the eREG and eTMF user requirements and associated test scripts. Reviewed the formal test runs, incidents and defects found during testing. Worked with the Engineering and Product Management teams to triage and prioritize all defects found during the test cycle and created the user acceptance test summary report. • Developed the eREG and eTMF client training materials and release notes for each product release.

Served as a validation consultant on small-to-medium content management implementation projects.• Developed and executed Validation Plans, Summary Reports, Traceability Matrices and test scripts (Integration, System, Regression, Operational Qualification and Performance Qualification).• Reviewed and approved functional and user acceptance test scripts authored by the Product Owners and Test teams, ensuring that requirements were traced to the correct test scripts and requirements were satisfied by the test scripts.• Conducted internal audits to ensure product team members’ adherence to SOPs and work instructions; produced audit reports and shared findings with impacted team members.• Handled difficult customer requests, earning a reputation for turning unhappy customers around.• Provided on-site product support during client user acceptance testing and go-live activities. • Facilitated daily war room meetings during UAT to review and prioritize defects found during testing. • Mentored 10+ offshore testing resources on good documentation practices, advanced product knowledge and customer relationship management.

Served as a business analyst on medium-to-large content management implementation projects.• Facilitated client configuration workshops, prioritizing all client requested configuration changes and enhancements.• Facilitated meetings with the project team to review the list of client-requested changes to ensure changes were within the project scope, budget and delivery timeframe. • Developed the system evaluation training materials and exercises to gather client feedback during the prototype evaluation period. • Developed product on-line User Guides and associated training materials. • Facilitated train-the-trainer sessions at client sites.• Provided on-site product support during client user acceptance testing and go-live activities.