At BioNTech, I partnered with Quality stakeholders across U.S. and Mainz operations to harmonize site-specific processes during the Veeva Vault deployment. I translated stakeholder requirements into controlled-document workflows, change-control routing, user roles, and role-based training assignments.
At Mayne Pharma, I owned MasterControl administration and served as the primary business-system SME for regulated Quality workflows. I led requirements and workflow design for a new electronic change-control module, then coordinated testing and launch training.
I managed quarterly system upgrades at Mayne Pharma, developing validation documentation and performing risk-based testing. I also verified audit trails, electronic signatures, and record integrity to support 21 CFR Part 11 controls.
Earlier, at Norwich Pharmaceuticals, I designed supplier-quality and change-control workflows for QUMAS and created reporting and escalation procedures after identifying underreporting of supplier issues. At Wyeth / Pfizer, I used SAP and Excel for supplier information and analysis and supported a cost-reduction initiative that contributed to $1.5 million in first-year budget reductions.
