• Ensure the Quality and compliance of GxP activities with respect to internal and/or customer procedures as well as FDA, ICH, EU and country specific regulations• Provide Quality oversight to Digital Systems (Automation & Laboratory Instrumentation) implementation projects across all phases of the System Development Lifecycle and associated artifacts across a Resilience site (Alachua)• Provide Quality oversight to Digital Systems and Cloud Infrastructure implementation projects across all phases of the System Development Lifecycle and associated artifacts across Resilience network as assigned• Serves as a liaison between site functions (including site Quality) and central Digital Quality function• Leads and works with cross functional team to assist in establishing a corporate-wide Digital Systems Governance Program (such as SDLC, Data Integrity, Risk Management) and instituting them on sites• Participate in development of a risk management strategy for Data Integrity controls (including testing) of digital systems procured by and/or designed/developed in house at Resilience • Lead/conduct/oversee training of Resilience personnel on CSV, Change Control, Data Integrity and on relevant Quality SOPs• Assist in establishing and facilitating the Governance boards for Digital Quality at network and site levels• Maintain systems in a state of inspection readiness• Recruits talent (contract and/or full time) as appropriate

•Setting IT direction, priorities, and goals for teams at strategic levels•Providing project management, QA, Audit, and regulatory oversight on GxP implementations•Creates procedures and infrastructure for Validation functions such as Validation Plan's and SOP's

•Providing project management, IT and regulatory oversight on GxP implementations•Manages personnel and contract organizations, including organizing and prioritizing group tasks, performing training, writing performance reviews, and managing validation budget.•Creates procedures and infrastructure for Validation functions such as Validation Master Plan’s and SOP’s.•Oversees the completion of projects through the development and approval of validation schedules, project plans, master plans, validation protocols and reports for systems that may be complex in nature. •Manages the activities and timelines for validation projects assigned per the project plan(s).•Reviews applicable change controls and maintenance activities for impact to validation and compliance.•Maintains current knowledge of US/EU regulatory requirements and standards applicable to validation and compliance, and provides guidance to the department personnel and other stakeholders.•As required, serves as the SME for validation during regulatory inspections, and/or audits.•Leads compliance audits as required. Interfaces with contract manufacturers to address documentation and compliance issues as related to validation activities.

Providing project management, IT and regulatory oversight on GxP implementations

Providing project management, IT and regulatory oversight on GLP implementations

•Manages the Quality Systems Group including seven direct reports, this involves hiring, performance reviews, work assignments and technical guidance•Reviews and approves validation deliverables•Provides project management and quality oversight on Gilead IT implementations including PDM IT systems move to off-site data center and Empower in the cloud (Amazon)•Manages GxP computer system deviation, investigation and CAPA processes in the Quality Systems department•Creates, reviews and updates Standard Operating Procedures associated with PDM IT Systems

•Performed compliance assessments on IT systems and network infrastructure•Issued compliance assessments and remediation plans for each IT system assessed•Worked with IT on network qualification including all operating procedures describing backup and restore per system, VMware implementation and disaster recovery.

•Hired and managed a team of five Sr. IT Compliance specialists•Helped create and implement IT remediation plan to get Novartis OTC back into manufacturing product •Facilitated and attended strategic planning meetings with Novartis OTC management•Performed compliance assessments on IT systems and infrastructure •Created and maintained project plan to implement and track remediation efforts•Facilitated daily team meetings to report status and escalate roadblocks to Novartis OTC management

•Worked with SNBL to modernize the computerized systems validation program to align more closely with GAMP 5 •Performed compliance assessments on IT systems and network infrastructure•Issued compliance assessments and remediation plans for each IT system assessed

•Built the Dendreon CSV group from a contractor based organization to a full time employee based group•Supported Dendreon PAI and three manufacturing site inspections in CA, NJ. and GA. with no observations attributed to computer systems•Responsible for all IT GxP related projects including timelines and budget•A member of the cross departmental IT steering committees (included QA, IT, manufacturing and clinical operations), this committee existed for each large project and was used as an escalation path for the project core teams•Helped map as-is and to-be business processes to streamline the processes before implementation into an electronic system•Modernized the Dendreon computerized systems validation program to align more closely with GAMP 5 and EU regulatory standards•Manage 10 direct reports and multiple contract resources•A member of the EASTCo IT steering committee, this committee presents project requests to executive management including timelines, budget and return on investment•Member of the Lean IT initiative tasked with streamlining and increasing IT effectiveness

•Manages all IT projects and IT compliance consultants for Veracord•Development and implementation of Veracord quality systems•Development and delivery of industry presentations•Ensures quality and timely completion of all IT and IT compliance projects•Responsible for all GXP and SOX related projects and issues

•Updating and modernizing the PDL master validation plans for computerized systems.•Project Manager on the Network Infrastructure move from the Fremont site to Redwood City, CA.•Manage 7 direct reports running 21 projects.•Review and approve all validation deliverables•On the PDL Computer Validation Consortium•A member of the IT Steering Committee, this committee plots the IT strategy of the company, approves implementations and prioritizes projects for the coming year.

•Designed and implemented the VaxGen project approval and evaluation process•Designed and implemented the VaxGen change control process•Review and approve all IT audit deliverables•Designed and implemented the GxP and SOX compliance and remediation plans for VaxGen IT•Project Manager on the implementation of the VaxGen Document Management System (MasterControl)•Project Manager on Validation of Clinical Data Management System (DataFAX)•Project Manager on Validation of Clinical Biostatistics Management System (SAS)•Project Manager on the implementation of the VaxGen Oracle ERP System (Oracle)•Senior member of the IT Steering Committee, this committee plots the IT strategy of the company, approves implementations and prioritizes projects for the coming year

•Project Manager on the Validation of Building Maintenance System (WonderWare)•Project Manager on the Validation of Clean in Place System (FactoryLink)•Project Manager on the Validation of Document Management Systems (Documentum and CoreDossier)•IT Quality over the Dey application Development group•Implemented network monitoring and notification at Dey•Helped evaluate and choose a CAPA System (Trackwise) •Designed software and Hardware Implementations to comply with 21 CFR part 11 and cGMP•Qualified the DEY L.P. network•Established the IT Compliance Group including the validation life cycle and 25 new Sop’s•Established the IT Compliance Audit Group to perform vender audits on computer software and hardware manufactures.•Designed and implemented the 21 CFR part 11 compliance and remediation plan for Dey L.P.•Developed and implemented training plans for IT application Development and IT Compliance on GxP, 21 CFR part 11 and procedures.