Leading an implementation of Global validation methodology across American R&D facilities. • Developing implementation plans consistent with global policies. • Developing local and functional procedures and guidelines as needed. • Performing Compliance Inventory across all existing local systems & equipment. • Assessing gaps and creating system review reports including mitigation plans. • Leading cross-functional teams including subject matter experts, IT support, and quality assurance to drive creation of validation documents using approved templates and processes.

Global Quality Management Systems application manager/owner and liaison for related validation and change management initiatives.(ETQ Reliance software platform-for GCC, CAPA, NCs, Audit management, etc.).• Overall day to day interaction with Senior Management regarding Global Quality System (EtQ Reliance platform-based).• Resolution management of Global Quality System issues related to Consent Decree activities.• Support for comprehensive Consent Decree resolution activities (NC/CAPA/GCC).• Identification and remediation of compliance risks in Global Quality System processes and procedures• Initiate and manage Nonconformance (NC) Investigations and Corrective Action/Preventive Action (CAPA) plans are implemented to resolve identified risks and to prevent potential risks.• Ensure that Global Change Controls (GCC), NC Investigations and CAPA plans are appropriate and addressed in a timely manner.• Review and approve NC/CAPA/GCC reports.• Participate in and provide quality leadership for routine Operations Meetings including System Reliability as well as Administration and Maintenance processes..• Supervised and mentored system support and business department staff regarding NC/CAPA/GCC processes and system-related operations.• Provided support to Regulatory Compliance during internal and external audits.

- Software Quality Engineering, Project Management, - Standardization & Compliance Auditor - RA/QA Documentation, System, & Process Management- Strategic Consulting & QMS Re-engineering- Six Sigma Process development and training- Risk-based SDLC Management (Risk Identification, Management, and Control).

Software testing and development team support with related technical documentation and validation efforts for multiple IT data management modules involving web access for autoantibody profiling/assay software, etc. Auditor for proprietary medical device software and underlying SDLC processes.o Internal QMS, SDLC, and regulated product system audits (ISO-9001-13485; 21CFR820; ISO/IEC 12207; ANSI-AAMI-IEC 62304-2006)o Comprehensive FDA/ISO/IEC Quality model, Risk Assessment/Management quality assessments and reviews (ISO-9126; ISO-14971; ISO-17799).o Quality and deployment assessments for selected SDLC projects within FDA regulated environmento Authorship and oversight of validation specifications, protocols and test scripts, project & task reports, software process flowcharts, and regulatory compliance assessments. o Testing and Evaluation coordination . o Retrospective system validation project support.

Responsible for regulatory affairs/compliance, system and process validation control, change management, and deployment/release. Internal and 3rd party SDLC quality assessments/audits and documentation, GxP research & validation studies, SOP and system design verifications, control, and commissioning, etc. Facilitator for all product/service analysis and quality review operations. Authorship of coursework and white papers for regulatory and quality compliance classes. Pharmaceutical & medical device system software quality engineering (specializing in GxP compliance). Overview of project type descriptions: o QMS, SDLC, and regulated product system audits (ISO-9001-13485; 21CFR820; ISO/IEC 12207; ANSI-AAMI-IEC 62304-2006)o Comprehensive FDA/ISO/IEC Quality model, Risk Assessment/Management, IT Security activities (ISO-9126; ISO-14971; ISO-17799), quality assessments and reviews.o Quality and deployment management for various ‘new system’ lifecycle development projects within federally regulated environments (21CFR, HIPAA, and Sarbanes-Oxley) o Validation of various “in-process control” software systems monitoring client manufacturing activities. o Authorship and oversight of validation specifications, protocols and test scripts, project & task reports, software process flowcharts (in accordance with relevant standards for corporate and facility policies), and regulatory compliance review. o Testing and Evaluation coordination for various system prototypes, migrations, multi-vendor systems, and vendor communication projects. o Retrospective system validation and retirement project support.

PAH CEESA Reporting Enhancement project and related support efforts for BT/GMR/Finance groups. Software Testing and Defect Management coordination supporting business team.

Several Software System Validation projects and related support work for IT and BioTech groups within the NCBP operation. NYBC utilizes the Cord Blood System to support the National Cord Blood Program (NCBP) Data Bank and related clinical and data management systems. This effort laid groundwork critical to FDA approval of HEMACORD (first licensed hematopoietic progenitor cells-cord cell therapy product).

SDLC Process documentation development, review, and enhancements.

Software Testing and Defect Management coordination supporting system prototype and enhancement project.

SDLC Process documentation review and enhancements. Software Testing and Defect Management coordination supporting affected business teams.

Authorship of selected validation specifications, protocols and test scripts, project & task reports, and regulatory compliance review. Testing and Evaluation coordination for CAPA system validation, migration, and retirement projects.

Several 3rd party and bespoke Software System Validation projects and related compliance support work for IT and Manufacturing groups within the Pfizer, Brooklyn pharmaceutical manufacturing facility.

SDLC Process documentation review and enhancements. Software Testing and Defect Management coordination supporting affected business and software development teams.

Testing and Evaluation coordination for various internal system development projects and 3rd party vendor deployments. Authorship of selected validation specifications, protocols and test scripts, project & task reports, software process flowcharts (in accordance with relevant standards and facility policies), and regulatory compliance review.

Software Development Team Product Analyst, Instructor, and Senior Technical Writer for the company’s flagship software product. Authored product specifications, best-practice qualifications, validation/testing procedures and refinements. Communication of industry and regulatory requirements to staff. Coordinated research to furnish compliant software use-case scenarios for development and review of functional specifications to verify and validate product performance, design, and flexibility. Assisted in development of ongoing partner program with ESRI GIS supplier (represented company and clients at both user conferences and focus groups to ensure expansion of market niches for both products in industrial and government sectors). Authored and edited Business Plans, Proposals, White Papers, etc. to support continuation and expansion of SDLC operations.

Hardware, networking, and software consulting contracts involving System Support/Re-engineering for client businesses. Analysis resulting in diagrams detailing business requirements for related application development solutions supporting Web and internal company network and desktop solutions. Directed client-specific research into quality management "best practices" for software testing packages and processes in the areas of: • SQE/SQA and SDLC supporting testing and deployment of Internet based applications; • Delineation of SDLC variants and requirement traceability; • Construction and management of test plans, test cases and scripts; • Introduction and deployment of automated defect-tracking systems (with cGMP/GxP focus); • Software training and obsolescence cycles.

Managed technical project staff. Served as Corrective Action Team (CAT) leader for Total Quality Management (TQM) and process mapping practices supporting CAPA system implementation. Represented Division for regional Quality Improvement Team (QIT) TQM bureau. Served as corporate technical committee consultant and facility representative for Eastern Region/Division operations. Managed industrial contract performance and compliance. Directed custom software application development and training for associated facilities. Provided technical direction, method regulation, and compliance audits for multiple facilities. Devised policies for both SQA and lab QC operations plan management affecting all division contracts. Provided contract specification and logistics control for materials, instrumentation, and software. Coordinated staff training and development. Validated Standard Operating Procedures (SOPs) and Quality Control Protocols. Designed cleaning processes and controlled validation of those processes.

Managed technical project staff. Managed compliance for federal contract performance (multiple EPA contracts). Directed custom software application development, training, and SQA for associated operations. Performed technical direction, method regulation, and compliance audits for multiple labs. Devised management policies for SQA/SQE and lab QC operations plan affecting all division contracts. Delineated contract specification and logistics control for materials, instrumentation, and software. Coordinated professional staff training and development operations. Validated Standard Operating Procedures (SOPs) and Quality Control Protocols. Improved software interface development operations for programmable data acquisition, QA/QC, and reporting functions. Developed and coordinated GLP/GxP production-teams in all reporting laboratories. Implemented cleaning processes and executed validation of those processes.

Implemented federal contract protocols. Developed and implemented custom project/data management application software and provided training for staff and external users. Managed staff and group operations. Directed QA/QC compliance, and training. Developed and implemented SOPs and QA/QC Protocols. Developed interfaces for all group computer operations involving data acquisition, QC programs, and specialized project reports. Authored and instituted software-specific application programs for federally regulated analytical protocols, and composed algorithms to provide applications with "on-line expert" verification of critical QC parameters.

Assisted Owner/CEO with P&L and personnel management authority; sales and contract management; analytical instrumentation (including authorship of proprietary LIMS system) software development, data management, programming, and deployment.