• Program Manager for Coordinating Technical Assessments across all 3P Suppliers within J&J (Pharma, Consumer, Medical Device)
• Coordinated Technical Assessment schedule and conducted introductory calls with J&J Suppliers
• Responsible for tracking review and close out of Technical Assessment Project Deliverables and all associated observations
• Coordinated Technical Assessment Program Level Metrics and Program Communications to Steering Committee Leadership and Governance Teams

• Provide leadership and Project Management support to facilitate vendor selection process for a Global Artwork Management System (Governance Structure, Vendor Demonstrations, Face to Face Vendor Presentations).
• Review of key vendor selection documentation (URS Responses, RFP Response, Statement of Work, Pricing and implementation strategy) and selection of AMS vendor per the outlined vendor selection criteria.
• Provide leadership and Project Management support to EU Regional Artwork Team

Performed Quality Due Diligence Audits across EU, India and USA for various Companies (Shire, Investment Bank)
Performed Pharmacovigilance Audits (Hospira)

• Performed Gap Analysis of Quality Management System (SOPs, Policies) to identify gaps and opportunities for Improvement to Current Policies and SOPs
• Updated and Developed SOPs and Policies to meet Combination Product regulatory requirements due to commercialization of Combination product in the US

• Developed and Delivered GMP Overview Training to Repackaging Facility

• Developed Process to manage Technically Unavoidable Particulate Profile (TUPP) Program at HSV Facility for both internal and External Supply as per APIC and IPEC Guidance
• Managed the coordination of the External TUPP Program to 3P Suppliers (Issuance of TUPP Questionnaire, Analysis of TUPP Data and Follow Through).

• Developed SOPs and Training Materials for Product Development, Process Validation, Risk Management and Technology Transfer

• PV Strategy Assessment of Pharmacovigilance core processeses (Case Management, Signal Management, Aggregate Reporting, etc)
• Conducted Interviews, workshops, process mapping, data analysis, information flow analysis to Provide Recommendations aligned with Industry Best Practices and Benchmarks.
• Developed Processes and drafted SOPs to support the following Key Processes: Signal Management, Benefit Risk Assessment, RMP, REMS & Post Authorization Safety Studies (PASS)