• Responsible for establishing the strategic roadmap for global electronic documentation and physical records management. • Global business application owner for Veeva Quality Docs electronic document management system and GMP physical records management system. Ensures solutions meet needs of growing biopharmaceutical organization while remaining validated and compliant with internal standards and applicable health authority regulations.• Leads enhancement prioritization, business implementation of system releases, and integrations with downstream systems (Compliance Wire, metrics system, and search engine). 19R3 Veeva platform release implemented successfully and on-time. • Project managing several site onboardings and document migrations; supporting Otezla divestiture.• Leads biweekly global documentation forum. Collaborates with business partners and sites to support audits, investigations, and observation closure.• Manages and develops 5 direct reports.• Member of Corporate GMP Data Integrity Team providing guidance for corporate standards, specifically Data Integrity, Computer Systems, and GMP Records Retention. Developed plan and response to address audit observation pertaining to control of primary data.

Earned 2 Platinum Encore Awards (leadership), 1 Gold Encore Award (collaboration), and 1 Silver Encore (connect; deliver).• Site Quality Manager for J&J Sterility Assurance (JJSA) Raritan Services R&D Site overseeing all quality functions (Study Quality Review/Approval, Documentation, Records Mgmt., Supplier Quality, Investigations, Audit, Equipment Management, Training, Systems and Equipment Validation, and Change Control) and responsible for establishing site quality strategy. • Successfully led JJSA 300+ manual document migration project from Documentum to Veeva Quality Docs on time and on budget. • Successfully closed JJSA internal audit observation regarding classification and qualification of calibration suppliers, and compliance with site-owned Supplier Quality Management governance. Established strategy and charter for JJSA to transition from site-owned Supplier Quality Management program to J&J Enterprise Supplier Quality Management program.• Established strategy to address JJSA spreadsheet validation internal audit observation, including development of risk assessment, validation governance, and project charter. • Established strategy, developed governance, chartered project and hired resource to remediate JJSA physical records management program. Included identification and protection for JJSA vital records, definition of retention periods for various GMP content, onsite inventory management, and offsite storage of legacy logbooks, notebooks, and validation records. • Led overall Documentum to Veeva Quality Docs (DS2TV) migration and execution as Business Lead for 12 J&J Enterprise Groups. Ensure end-state, integrated, solution meets business, compliance, and data integrity requirements across all impacted functions (E2E). Partner with key business leaders to engage SMEs & Functional Leads. • Global Quality Services process owner for Document Management, Change Control, and Records Management.

Earned 2 Platinum Encore Awards (leadership) and 1 Silver Encore Award (deliver).• Global business owner of Documentum (docspace) electronic document management system for Janssen and 20 corporate groups. Ensured audit-ready and validated state of system and on-going operational performance. Ensured operation of interfaces with ComplianceWire, SAP, ERIS (regulatory), and SAP Manufacturing Execution System. • Oversaw network of 100 global docspace business administrators for user access management. Led monthly global forum. • Owned system enhancement request process. Liaised with IT and Computer Systems Validation (CSV) partners to ensure compliance with System Development Life Cycle (SDLC) and Quality Computer System Validation (QCSV) requirements. Conducted UAT testing through HP ALM. • Compliance Wire administrator• Led document coordination services for Janssen Virtual Organizations• Global contact for audit of Documentum (docspace) system and process. • Developed binomial sampling plan for global quality systems audit trail review. • Special Projects:o Supported identification, ranking, and harmonization of critical requirements for Janssen replacement document management system. o Led migration of 1,000 documents for Supplier Material Quality (Large Molecule)o Supported closure of Gurabo CAPA for control of primary data sheets due to FDA observation. Liaised with all global Janssen sites to educate site quality leads on control printing capability and guide how to assess and close data integrity compliance gap. Led global meeting series on methods and technology to control primary data sheets. Initiated improvements to control printing functionality in docspace. • Led closure of internal audit observation for Records and Information Management (RIM). Implemented RIM program and infrastructure inclusive of governance procedures, training, and Records Coordinator network. Interim process owner for RIM.

Responsible for Trade Customization (TC) supply chain operation compliance oversight/strategy• Led effort for North America Trade Customization to comply with Training CAPA and align to CFR Part 211.25 and Corporate Standard. Developed TC compliance training program. Implemented and configured Compliance Wire (LMS) to enable paperless learning management. Met all CAPA objectives on-time. • Developed training program for sales and marketing functions on promotional assembly compliance to reduce legal and quality risk to J&J while meeting customer needs. • Led external supplier training pilot program to enable closed-loop delivery of trainings related to design and assembly of displays. Participated in development of Consumer External Supplier Training Guideline in collaboration with Consumer Training Center of Excellence.• Developed and implemented Trade Unit Specification Approval process to enable 40 J&J planners to approve final design for trade unit prior to assembly at our supplier sites. • Developed a tracking/trending system for J&J planners to record supplier misses which were not related to product quality but had an adverse impact to customer service levels. • Identified specification system requirements and business impact assessments for Trade Customization function globally. Defined use of Trade Unit and Sub-Component part types including work instructions and approval matrixes for each region. Tracked project milestones and presented results to D1, D2, VP, and EVP levels.• Supported successful implementation of Electronic Label Verification for 4 assembly sites (2 QPSI; 2 Menasha). • Training Process Owner and Compliance Wire Administrator.

• Developed and led Enterprise Resource Planning (ERP) System Selection and Implementation consulting practice for mid-size manufacturers and distributors. Developed practice strategy, consulting offerings, marketing materials, pricing model, and consultant support structure. Responsible for budgets, project schedules and customer satisfaction. • Led identification of critical business requirements for multi-site manufacturers in a variety of industries. Developed Request for Proposals (RFP), identified software solutions/vendors to respond to RFP. Analyzed responses, hosted top contenders for onsite demonstrations, and assisted client in system selection. Liaised with client and software vendor to define configuration requirements and support software implementation. Authored operational procedures and training materials and led change management. • Led successful delivery of operational improvements for manufacturers, distributors, and service organizations. Served as technical expert on sales calls. Developed proposals outlining project scope, resources, and pricing for services. Managed project budgets, schedules, and resources. Led projects successfully and on-time to completion.

Managed the planning and execution of 25 different pharmaceutical product submission batches, resulting in 100% on-time placement on stability and 100% on-time shipment of packaged product for bio studies. Developed system tools and best practices for supply chain planning and finished goods costing in newly implemented ERP system (JDE OneWorld).

Planned and scheduled Solgar brand bulk vitamin batches to meet demand for the U.S. and 28 international countries. Maintained appropriate inventory levels of approx. 400 different bulk vitamins ($9.1 million of inventory) and 700 different raw material ingredients ($9.4 million of inventory). Utilized JD Edwards ERP system.

Supported delivery of operational improvements for manufacturers, distributors, and service organizations.