VP of Quality Assurance

• Feb 2019 - Present

Principal

• Jan 2011 - Feb 2019

Managed client engagements and provided professional services in Software Quality Assurance, Computer System Validation, Quality Management Systems, and Pharmacovigilance. Examples: ► Led a medical software developer in the development and implementation of FDA 21 CFR 820 and FDA 21 CFR 11 compliant quality programs, including vendor assessment, change control, validation, corrective and preventive action CAPA), internal audit, document management, and periodic management review. ► Served as acting Quality Assurance Director for a start-up medical device company. ► Audited the software quality assurance and validation practices of CROs, medical device manufacturers, and software vendors to identify regulatory compliance gaps and areas of improvement. ► Assessed a medical device manufacturer’s current software validation practices for SAP and quality management systems to identify compliance gaps and inefficiencies. Implemented risk-based CSV practices to close regulatory compliance gaps and expedite the validation of low-risk changes. ► Implemented a risk-based software validation program for a pharmaceutical distribution company. ► Led corporate Pharmacovigilance and Medical Information organizations through financial analyses of out-sourcing and in-sourcing opportunities. Managed the resulting out-sourcing and in-sourcing projects to reduce operational costs while retaining regulatory compliance. ► Managed initiative to consolidate 350+ regional case processing procedures into a global program to enable deployment of a single safety database and reduce the number of case processing vendors. Show less

Senior Manager

• 2009 - 2010

Managed client engagements and provided professional services in Software Quality Assurance, Computer System Validation, Pharmacovigilance, and HEOR/Clinical Epidemiology. Examples: ► Led several software development companies in preparation for their first audits by FDA-regulated clients. Audited companies’ current practices and provided Compliance Implementation Plans. ► Performed 3rd party audits of software vendors and SAAS companies on behalf of regulated companies. Successful audits provided rationale for reduced validation activities. ► Led a global pharmacovigilance (PV) organization in the development and implementation of a new drug safety surveillance process and documentation practices. Planned and managed activities across 11 sub-teams while keeping executive management apprised of progress and issues. ► Managed the implementation of automated, electronic distribution of Safety Notification Letters to decrease distribution costs and expedite delivery to clinical investigators. ► Managed the development and execution of a strategic business plan for a new HEOR/clinical epidemiology organization. Strategic topics included organizational mission, goals, products and services, staff structure, marketing, metrics, and supporting tools. Show less

Manager

• 2007 - 2008

Managed client engagements and provided professional services in Computer System Validation, Software Quality, Clinical Operations, and Pharmacovigilance. Examples: ► Audited and assessed current-state practices of software vendors and SAAS providers vs. US and international regulatory expectations. Prepared detailed Implementation Plans to achieve compliance. ► Led multiple international companies through development and deployment of pharmacovigilance signal (PV) detection and safety signal management programs. ► Established baseline financial, productivity, and cycle time performance metrics for a global clinical pharmaceutical clinical development organization and bench-marked the organization’s performance with industry leaders. Show less

Manager, Software Quality and Quality Systems

• 2004 - 2007

Managed regulatory compliance and investment strategies and associated projects for computer systems.► Managed a staff of software quality assurance (validation) professionals and provided software quality testing services for U.S. and international IT investments.► Prepared pharmaceutical and nutritional product distribution centers for European regulatory agency inspections by managing the execution of site automation validation activities.► Implemented quality policy and SDLC risk-based practices to lower software testing costs, improve software quality, and retain compliance with global regulatory requirements and standards including FDA 21 CFR 210/211 and Part 11, ICH Q7 and Q9, EU Annex 11, Sarbanes-Oxley, HIPAA, GAMP and PIC/S. ► Represented Abbott during FDA, international, customer, and internal audits.► Developed a global long-range strategic plan aligned with corporate vision outlining the implementation strategies, costs, and milestones for 28 systems at 23 sites. ► Developed an annual and long-range capital investment plan. Performed cost/benefit (ROI) analyses and obtained executive management support for key projects. ► Implemented a governance infrastructure for the prioritization of global IT requests. Led global business and IT team through the screening and prioritization of 150-200 project requests annually.► Managed a staff of program managers with responsibility for implementing computerized quality systems.► Implemented a system deployment continuous improvement program that resulted in system implementation cost savings for international sites. Show less

Manager, Division Systems Quality Assurance

• 2000 - 2004

Managed computer systems and document strategies, policies, and projects. ► Managed personnel in 5 Quality Assurance & Systems departments. Range of responsibilities included software quality assurance, documentation change control, product label management, record center management, lab system automation, 21 CFR Part 11 compliance, and implementation of key division-wide computer systems.► Developed a division-wide computer system selection, development, and deployment strategy then obtained funding for the associated projects. Led nation-wide governance team of business and IT representatives through periodic review of the strategy and prioritization of proposed projects.► Oversaw the development, software quality assurance testing, and implementation of computer systems.► Represented Abbott during FDA, international, customer, and internal audits.► Managed large staff of employees and contract personnel.► Managed department budgets and capital projects. Show less

Program Manager, Quality Systems

• 1999 - 2000

Managed computer systems activities for laboratory and quality assurance organizations.► Developed plan to automate laboratory information systems to enable future cost reductions. Designed and led a study to determine feasibility of plan. Championed plan to obtain funding from executive management.► Oversaw the development, software quality testing, and implementation of Quality Assurance Systems ► Represented Abbott during FDA, international, customer, and internal audits.

Project Manager, Information Systems

• 1995 - 1997

Managed Quality systems development and ERP implementation projects. ► Led the development and software quality assurance testing of ERP modifications and enhancements by managing the efforts of a team of 12 programmers, test protocol writers, and technical writers. ► Led the ERP implementation teams for 15 manufacturing product lines. ► Utilized expertise in ERP Manufacturing, Inventory Control, Warehousing, and Laboratory Management modules to facilitate process improvement changes among multiple business functions in Illinois and Puerto Rico. Show less

IT Project Manager

• 1988 - 1995

Managed Information Systems projects. Key responsibilities included system requirement definition, vendor selection, software development management, software testing, system implementation, and user training. ► Managed the design, development and implementation of an integrated engineering, manufacturing, and financial system used for production tracking, capacity planning, payroll calculation, employee development reporting, labor analyses, and quality control. ► Led projects within the company's integrated manufacturing and order processing system (ERP). Areas of experience include manufacturing order processing, cost accounting, capacity planning, purchasing/procurement, inventory control, MRP/MPS, sales performance reporting, and order management. ► Led financial and Human Resource (HR) system projects, including the development of a 401K system. Other financial projects include the implementation of a new payroll system, a general ledger system, an accounts payable system, a fixed assets system, and an HR system. Show less