Successful Leader in cGxP Quality and Regulatory Affairs

Summary of Qualifications

• Over ** years’ experience in medical device and pharmaceuticals with an emphasis in quality systems management and regulatory functions. A proven track record for building defendable administrative positions that met the challenge of regulatory barriers. Leadership with relevant and timely solutions that satisfy business and compliance objectives.

• Quality and Regulatory Management Representative for several successful FDA Inspections and Investigations: Managed the approval of Food and Drug Administration FDA Warning Letter Close-out and Recall Close-outs for 3 separate organizations; generated FDA reviewed and approved corporate investigations and responses for FDA 483s and Warning Letters; and successfully hosted two (2) concurrent Quality Inspections with no Warning Letter, 483s, or discussion points issued.

• Managed Corporate Master Audit Plan, Schedules and Reporting for both Internal and External Auditing (Vendor Management and Supplier Quality), with ownership and management of the Corporate Quality Management System, Quality Plan, and Quality Objectives.

• Provides technical leadership in the analysis of risks and post market root cause analysis to remove barriers to the marketing of finished goods and services.

• Functional and System Ownership of Corporate Quality Systems (manual, hybrid and electronic): Document Management System, Change Management, Risk and CAPA Management Systems and Validation Master Plan.

• Author, Reviewer, and Approver of quality documents that included: IQ/OQ/PQs, design verification/validation, customer product requirements and specifications, requirement traceability matrices, test management plans, product risk plans/reports, and design and process FMECAs, CAPAs, Risk Management Plans, and Quality Improvement Plans.

• Responsible for the review and approval of design history files(DHF), FDA device master records(DMR), European (EU)Technical File/Design Dossier for CE Markings Approval and FDA registration of Class I, 510k for Class II and Class III PMA per 21CFR Part 820, Part 11, FDA's General Principles of Software Validation; ISO/IEC 25010, ISO 60601 and IEC 620304.

• Working knowledge of regulations/standards that includes, but not limited to:

Food and Drug Administration (FDA): 21CFR Part 820, 21CFR 807, 21CFR 803, Part 21CFR Part 211, 21CFR Part 210, 21CFR Part 11;

European Commission’s Medical Device Directives: 93/42/EEC;

European Medical Device Regulation (EU-MDR): 2017/745, Health Canada: SOR/98-282;

Japan Pharmaceutical and Medical Devices Agency (PMDA): MHLW Ord.136, MHLW Ord. 169;

International Organization for Standards: ISO 9001, ISO 13485, ISO 14971, ISO/IEC 12207 and ISO 62304;

U.S. Securities and Exchange Commission (SEC): Sarbanes-Oxley Act (SOX) Section 302 - Corporate Responsibility for Financial Reports, Section 404 Management Assessment of Internal Controls (ICFR);

U.S. - EU Safe Harbor Privacy - exporting and data transfers;

Centers for Medicare & Medicaid Services (CMS): 42 CFR 433, subpart C. Mechanized Claims Processing and Information Retrieval Systems; Medicare and Medicaid Electronic Health Care Record (EHR), 42 CFR Part 455, Program Integrity: Medicaid;42 CFR Part 456, Utilization Control; Enrollment and Eligibility Medicaid Management Systems (EEMMS), Health Information Technology Transfer (HITT), Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule – Medical Records; Protected Health Information (PHI); Medicaid Information Technology Architecture (MITA),

• Education: Bachelor of Science in Quality Systems Management, Certified Six Sigma Green Belt and Certified Private Detective Employee

• Quality Manager and lead for the review and approval of the design, development, implementation, and maintenance of software delivery methods that provided access and function remotely as a web-based service (SaaS); and the development of test plans, test scripts, deviation and bug tracking, and validation protocols for software embedded with medical devices and software as a medical device (SaMD).

• Creatively leads the completion tasks by tackling the ‘true’ root cause or ‘actual’ customer requirements.

• Champions change by facilitating the implementation and acceptance of innovative ideas in the workplace.

• Manages projects in a fashion that balances strategic initiatives and tactical requirements.

• Intelligently guides the use of statistics to develop standards and methods for inspection, testing, and evaluation of incoming, in-process, and finished goods for existing products.

Experience

Employer

From

To

Position

Owner and CEO of QARS Solutions Contract and Consulting Services

Sep 2000

Present

Independent Consultant, Quality Assurance and Regulatory Compliance Advisor and Senior Technical Quality Auditor

Summary List of Clients

Bio-Life/Pharma/Medical Device: Abbott, Anchor Surgical, Baxter, Boston Scientific, Carematix, Electric Mobility, Eli Lilly, Fresenius-Kabi; GE Healthcare, Hospira, IBM Watson Healthcare, Illumina, Indexx, Medtronic, Pfizer, Richardson Electronics, Schering-Plough, Sigma Aldrich, Takeda

Government Healthcare Agencies: State of Georgia, State of Louisiana, State of Ohio

Financial Services: World Bank – International Finance Corporation (IFC)

Commercial, Life and Health Insurance: Allstate, Hartford Life, United Healthcare

QARS Solutions Sep 2000 – Present

Various long and short termed projects are providing advisory and management support concentrated in Quality Assurance, Regulatory Affairs, and Validation Management.

• Assigned the responsibility to establish, implement and manage quality management systems;

• Assessment of organization hierarchical structure baselined to industry standards and existing operating procedures to improve and expand defined roles and responsibilities;

• Analyzed business requirements, processes, risks, and problem data (complaints, investigations, and non-conformance) for trends and developing issues;

• Evaluated research and development, design and process engineering, and production management for the identification of mission-critical operations, systems, and parts

• Developed and managed Internal and external Audit Management Programs;

• Generated Audit Summaries, Assessment Reports and Regulatory Investigation presentations for Senior Management Teams with the recommendation on possible corrective and preventative action plans;

• Managed, reviewed and approved follow-up assessments of nonconformance, recall notifications, FDA submission

Summary Highlights of Recent Project Work Experiences

Zimmer-Biomet – Quality Manager (Contract) Feb 2017 – Present

• Led a team of up to 12 quality engineering contractors to provide process validation review and approval support (procedures, cleaning, thermal plating and polyethylene processing, equipment, and utilities) for a high-visibility production and process control system remediation projects.

• Provide management and leadership support for the multiple North Campus’ Production and Process Control’s Corrective and Preventative Action (CAPA) implementation projects.

• Submit quarterly FDA 483 Observation reporting updates related to the progress of the current corrective action activities related to the systemic process validation findings and the supporting production and process control CAPAs.

• Served as the project lead for the development of procedures, project plan, and execution of the remediation of the site’s validation master plan for a systemic Corrective Action Preventative Action (CAPA) project.

• Participant in the preliminary GAP Analysis and Impact assessment for Regulatory and QMS changes related to planning for possible device recertification and reclassification to EU-MDR.

• Created and revised Quality Management Procedures to address Validation Management, Equipment Qualification and Decommission, Design Transfer Verification and requalification, Environmental Health and Safety harmonization.

IBM Watson – Defect and Deviation Lead (Contract) Aug 2016 – Dec 2016

• Reviewed and categorized system testing defects for development review and investigations.

• Review and approved corrective action plans and executed protocols with the development team, testing team and Medical Device Client.

• Generated and issued Deviation plan, weekly reports, and test phase reports.

Richardson Electronics – Acting Director of Quality/ Management Representative (Contract) Dec 2015 – Jul 2016

• Setup the corporation’s new medical device division Quality Management Systems’ framework, policies, and procedures compliant with the requirement(s) of the quality system regulations.

• Performed the 21CFR Part 11, SOX and HIPPA compliance auditing for the newly acquired enterprise resource planning (ERP) software. Approver for the system integration plan to ensure the for electronic records validation requirements are implemented.

• Ensured the organization’s training and implementation of the Quality System identified roles and responsibilities that focused on accountability, management, and compliance.

• Hired and staffed quality management team to provide both quality assurance and quality control functions within the organization.

Carematix- Director of Quality (Fulltime converted to Retainer Contract) Apr 2009 – Present

• Revise and update the existing corporate quality management system compliant to quality system regulations. Ensured the organization’s documentation identified roles and responsibilities including accountability.

• Prepared 510k deliverables and obtained successful 510k approval for the safety and effectiveness information submitted by the requirements of 21 CFR 807.92 for the following devices:

Cardiovascular Monitoring Devices Radiofrequency Physiological Signal Transmitters and Receivers –Wellness System - intended to gather and transmit patient data from the home site or remote location to caregivers at a clinical facility where it provides supplemental information for the care of the patient.

System, Measurement, Blood-Pressure, Non-Invasive – wireless non-invasive blood pressure measurement device intended to measure systolic, diastolic blood pressure and pulse rate of an adult individual; the device can transmit the readings through wireless communication for record archiving and review. (Over the counter use)

SQA Services Lead Auditor (Contract) Mar 2009 – Aug 2015

• Completed national and global audits for applicable FDA regulations including 21 CFR Parts 11, 58, 210,211 820; ISO standards, CDRH guidelines, and EMEA medical device directives.

• Performed assessments and evaluation of the following aspects/scope: Internal Controls, Analytical Procedures, Test of Controls Data integrity including: prevention of deletion, poor transcriptions and omission, Authorized / Unauthorized changes to data and documents, Critical Alarms handling (Process), Audit trails, Security by function, Security by Transaction, Report Generation and distribution. and Defects and Deviation Management.

• Work with FDA, EMEA, ISO/EN/CE, MITA, MMIS, FRA, IEEE, ICFR, SOX, HIPAA, GAMP, PDMA, COBIT, COSO, ITIL, and other applicable industry and government agency standards and qualifications.

State of Ohio Feb 2008 – Jun 2008; State of Georgia Jun 2008 – Mar 2009 and the State of Louisiana Sep 2010 – Apr 2011 Medicaid Management Information Systems (MMIS) Replacement Project(s)

Design, Development and Implementation IV&V Lead (Contract)

• Responsible for determining the focus and direction of the Independent Verification and Validation (IV&V) Project team assessments of Design Development and Implementation (DDI) tasks and activities, including but not limited to the creation, review or approval: Business Requirements; Functional Specification; Technical Specification, Test Plan; Test Cases/Test Scripts and execution; Deviation Plans; Bug Tracking Reports; and Production Readiness Reports.

• Performed evaluation of the proposed business and technical requirement and revised action plan solution(s). Provided assessment and audit reports for recommended changes/revisions to technical documentation.

World Bank-International Finance Corporation - Senior Project Manager – Independent Verification and Validation (Contract) Jan 2007 – Feb 2008

• Responsible for the development and implementation of the test and validation methodology and standards of operations for an Independent Verification and Validation [IV&V] Service practice.

• Performed assessments of all computer systems related implementation and validation projects including but not limited to: Data Warehousing; Data Migration; front-end and back-end processing; electronic records: electronic signature processing; technology transformation and technology consolidation/portfolio management.

• Evaluated, revised and approved global and departmental business domain areas processes and procedures including but not limited to: Investment operations, risk management, accounting, and financial reporting, Treasury, Business data management, integration and reporting, document management, portfolio management, data warehousing, Human Resources, and Information Security.

Electric Mobility-Director of Quality (Contract) Sep 2006 – Jan 2007

• Led the Senior Management Team’s presentation that obtained the approval of Warning Letter corrective action plan and product recall plans presented to CDER oversight panel.

• Provided technical reviews of Field Investigations, Labeling, Packaging, Processing and Maintenance projects to sustain quality products.

• Provided leadership and management support to both senior management the Quality Assurance department including technical expert consulting staff.

• Managed and facilitated the remediation and revalidation of Intended Use Statements, Base Risk Assessments, CE Marks, 510k and PMA evaluation of new product development, product model change, and retirements

Boston Scientific - Senior Quality Assurance Engineer (Contract) Jan 2006 – Sep 2006

• Reviewed/revised and approved Device Master Records/Technical Files; Design History Files; Device History Records and Master Validation Files for remediation.

• Investigated Engineering Change Control Requests, Product, Design and Process Failure Mode Effect Analysis [FMEA]; Root Cause Analysis Deliverables, Standard Operation Procedures, Work Instructions, System Development Deliverables, other Quality System records, and documentation

Boston Scientific – Senior Quality Auditor (Contract) Aug 2003 – Jan 2006

• Developed audit plan and schedules for vendor approval, recertification, supplier quality and internal audits of the department’s systems, products, processes for compliance and conformance.

• Review of project plans and project deliverables, quality manuals, procedures, inspection documentation, quality and production records, procurement documents, reports and other documentation related to the audit objectives, quality assurance standards, and global regulations.

• Analyzed business requirements, process, and problem data for trends and developing issues; Assessment employee work baseline and compared to standard operating procedures and defined roles and responsibilities

• Developed detailed Audit and Assessment Reports and provided support to Senior Management Teams with a recommendation on possible corrective and preventative action plans;

• Managed the review and approval of submitted corrective actions plans and planned follow-up and surveillance audits for the assessments of nonconformance correction

Employer

From

To

Position

EDS-Solcorp - Software Development and Implementation

Aug 1996

Aug 2000

Full Time Employee Consultant

IT Consulting experience as a Senior Software Quality Assurance Engineer and Validation Quality Engineer Consultant, IT/Quality System Auditor, System Analyst, Senior Business Analyst, System Testing Coordinator, Quality Assurance Manager, Data Analyst.

Summary of Projects

Lincoln Life, Amerus, Liberty Insurance and Abbey National Financial

EDS-Solcorp Aug 1996 – Aug 2000

Extensive travel to provide onsite technical consulting for International and National projects.

Worked in all phases of System Development Life Cycle and experience with various Software Lifecycle Methodologies: Project Initiation and Definition, System Development, Analysis and Documentation, System Development and Design, Implementation and Systems Support.

Education

Master in Management and Leadership – Western Governors University, IN – target completion date August 2019

BS in Quality Systems Management – National Graduate Institute of Quality Management, MA

Six Sigma Green Belt Certificate – Juran Institute, MA

Certified Private Detective Employee: 2015 -2021 – Fidelity Investigative Training Academy

ISO 9001:2000 Lead Auditor RABQSA Certified – American Society for Quality (ASQ)

Certified Quality Auditor 2005 – 2009; and 2011 – 2014 – American Society for Quality ASQ

Certified Scrum Master 2004 – 2007 ADM (Agile Alliance)

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