Victor Thomas Email & Phone Number

Creating and implementing recommendations for people subject to Consent Decrees, ensuring FDA regulatory compliance in processes and systems, and providing staff augmentation to support healthcare and manufacturing IT needs. VMX designated a fully dedicated Software Quality Director with a depth of experience to make sound and timely recommendations to aid decision-making. The Software Quality Director was critical in evaluating people, processes, and technologies to ensure the projects' success.Provided compliance consulting services for client’s transformation to the” unleashing the power of Data” that involved seven technical workstreams, ~8000 infrastructure resources, and 400 applications all concurrent.• Developed an overall Master Plan to coordinate and educate ~ 300 technical and business associates• Lead a Compliance team that consisted of three supervisors and thirty-six engineers

Sarasota, Florida, Us

Responsibility include the creation of a new business unit focusing in the Life Science arena offering technologies and processes bench marking from industries that are advance in manufacturing methodologies. Provided consulting services for Accenture’s clients made up of hundreds of technical personnel worldwide in the areas of Software Quality Management and Regulatory Compliance Overview, Business Development, Project Management, and Consulting Services. Client: Accenture for Takeda• Developed Master Plan with four sub qualification Plans that coordinated seven technical workstreams that reduced the monthly burn rate by $500M• Managed thirty-none compliance engineers and supervisors that provided compliance oversight for applications migrations, technical infrastructure development/implementation, compliance process generations and documentation for a $35 MM and more Digital Transformation• Managed activities for cross-functional teams and coordinate technology and implementation plans with internal and external resources (domestic and international teams) application design.• Managed the delivery of new processes within the context of a customer consultative relationship to ensure the highest level of quality and client satisfaction process design• Oversaw a Compliance team of three supervisors and thirty-six engineers.Client: Accenture for Johnson & Johnson• Devised integrated data migration and process validation principles to migrate 15,000 workloads (servers and data) from physical data centers to Software Defined Data Centers• Drafted protocols, specification, testing documentation to qualify software tools used to migrate workloads to Software Defined Data Centers, thus reducing cost of migration by 300%• Directed the activities of six engineers that drafted requirement and testing documentation for Solution Manager for a two-month implementation that saved client engagement worth 400 million

Sarasota, Florida, Us

Annapolis, Md, Us

Coming into this role, I developed the business plan and organizational structure for Syndicus’ Life Sciences practices that projects revenues of $2.1 million/year and a project growth rate of 15 percent/year. I have also created strategic alliances with industry experts and other Life Sciences practices to provide a “one-stop-shop" experience for pharmaceutical and other healthcare clients.My current project work/accomplishments include:-- Serving as an embedded member of the CSV QA global organization mentoring/plant QA personnel – a role in which I am providing project management, coaching, leadership and third-party regulation oversight for a pharmaceutical company under a Consent Decree. As of December 2013, we are beginning the plant certification process.-- Serving as an embedded member/third-party regulatory oversight of the automation team responsible for the implementation of a liquid compounding facility that includes packing operations. As of December 2013, we are starting the plant operations process.

Paris La Défense, France, Fr

Over a four-year period, I had the opportunity to mentor and coach in-house validation engineers, quality personnel and other technical staff on these efforts: I:(1) Led the validation of a product authentication (serialization) using the GS10 standard using pending regulation from Turkey, Brazil, and India, which included a validation master plan (VMP) for a global implementation (reduced redundant workflow by 40-60 percent). I also served as a team member for this client’s Global Strategic board -- determining overall process and plans for a $14 MM five-year rollout of product authentification. (2) Led the validation of an upgrade for ARISg software used to support the Pharmacovigilance process, which included validation management for E2B gateway implementation with the EMA and FDA authorities, and established the change management process for a hosted solution. (3) Led the validation scope of work (validation documentation and governance processes) to consolidate all of a high-profile client’s websites into one web-based Vignette Content Management system using an iterative deployment model. As a result, the client achieved multiple significant savings: (1) a 400-percent reduction in cost of quality, and (2) a 200-percent reduction in cycle time, as well as an 800-percent reduction in error generation. We also converted the iterative deployment model into an agile software deployment to generate new functionality such as on-demand clinical case studies on a weekly basis. (4) I was one of the first individuals in the United States to validate an Oracle e-Business suite implementation – one that spanned three continents and five countries and generated $4 billion/year. This included developing all validation documentation, as well as mentoring 300 project personnel to apply the principal of risk management to shape the testing strategy and implementation of controls for electronic records for regulation adherence while under a Consent Decree.

I was an integral part of the CSV rollout for a pharmaceutical facility under a Consent Decree – one that did not have/require third-party regulation oversight. As the “floor general,” I evaluated the technical competence of employees within individual divisions/plants and identified and empowered leaders within those plants. I floated from “hot spot to hot spot,” meaning that wherever issues arose (United States or abroad), I worked with plant staff to brainstorm solutions and helped guide them on implementation.My accomplishments included “closing” every significant step/issue under the CSV rollout, directing a team of site and consultant personnel to implement IT applications using a leveraging scheme that reduced cost and time to system release by 85 percent.

Tn

I and a partner established this venture to provide enterprise solutions to healthcare and Life Sciences companies facing Consent Decree and other regulatory compliance issues. I evaluated the technical competence of staff, identified deficiencies and empowered technical, regulatory and business staff to more effectively manage/run their facilities to ensure compliance. Some of my project-specific work/accomplishments include:-- Directing a team of consultants in performing CFR Part 11 Remediation in Laboratory, Manufacturing, and Facilities for a Pharmaceutical Facilities in Puerto Rico. Significant Step completions were on time.-- Developing the CFR Part 11 Compliance Strategy for the Project Execution Office to implement for FDA regulated in Schering Plough.-- Serving a $11.7 million capital project for Computer System Validation/Part 11 technical and procedural remediation for Pharmaceutical Facilities in Puerto Rico that were under a Consent Decree. I helped this client achieve a total savings of $8 million.-- Serving as the lead member of an internal audit team for the Pre Approval Inspection (PAI) for a new drug application (NDA), which resulted in a “no comment” approval for CSV documentation from the regulating agency. -- Generating a CSV Master Plan for a Consent Decree site in Puerto Rico.-- Training both permanent and consultant validation engineers in CSV documentation generation for a new risk based validation standard.-- Establishing the validation methodology used to validate a customized LIMS application for a Consent Decree site within a six-month timeframe for site significant step closeout.-- Generating CSV life cycle document (specifications, protocols, Trace Matrices, summary reports) for solid dosage Pharmaceutical under a Consent Decree that included manufacturing, laboratory and AS400 Platform IT systems.

B.S., Mechanical Engineering

Master Of Science (Equivalent), Nuclear Engineering