George Hollen, Mba Email & Phone Number

Wilmington, North Carolina, United States

• Independently lead multiple IRT/RTSM projects of high complexity.• Act as primary point of contact for clients, keeping them apprised of all project developments while maintaining stellar client satisfaction. • Build effective partnerships with other internal teams to move project through all phases of the development process. • Develop and maintain project schedule, identify and track milestones and identify and manage cross-functional dependencies and risks.• Act as subject matter expert on client clinical study protocol • Manage ongoing reporting of project health and profitability to internal and external stakeholders. • Conduct end- user training. • Manage issue resolution for studies in maintenance, including troubleshooting and root cause analysis, where necessary• Understand the functional business process across the entire organization.• Participate in and/or lead training and mentoring efforts of project team members in areas of identified expertise.• Leads internal initiatives and projects that enhance delivery capability.

Wilmington, North Carolina

• Perform review/approval of test cases for mid-level and other Senior Quality Analysts.• Define scope of validation efforts for change controls• Provide guidance on testing and departmental objectives.• Perform IRT / Interface validation & UAT documentation including writing and executing test scripts based on system design specifications and protocols.• Review and validate Supplies Distribution Management (SDM) configuration of depots, material groups, types, and statuses, initial and re-supply ordering plans, and inventory alerts• Provide review of system design specifications prior to build to ensure validity.• Conduct Production Readiness Reviews prior to system release into production.• Train junior staff on any new or existing processes.• Perform routine auditing functions ensuring that the IRT department is operating in compliance with PPD approved procedures as well as current FDA regulations (21 CFR Part 11).• Perform special project validations such as PPD designated tier 4 computer systems validations.• Create/Update departmental guidance documents and/or manual testing templates.• Utilize Jira Software to log and track project issues and activity• Participate in Lean Six Sigma process improvement projects. Yellow Belt Certification.

Wilmington, North Carolina Area

• Perform IRT / Interface validation documentation including writing and executing test scripts based on system design specifications.• Provide review of system design specifications prior to build to ensure validity. • Perform document management functions including but not limited to: document review, organization and archiving• Perform routine auditing functions ensuring that the IRT department is operating in compliance with PPD approved procedures as well as current FDA regulations (21 CFR Part 11).

• Ensured computer validation activities and use of electronic records are in compliance with internal procedures, policies, and international guidelines and regulations. • Performed detailed internal audits and reviews of computer system validation and change control documentation to confirm consistency, accuracy, and compliance to PPD-approved procedures. • Participated on vendor software assessments and contract service providers.• Served as an audit host for external clients.• Consulted and mentored computer validation coordinators and teams in the proper creation and execution of validation plans and testing scenarios.• Trained employees on FDA requirements for electronic records and signatures. • Completed American Society for Quality (ASQ) Certified Quality Auditor (CQA) Certification.

Supervised and led a GMP pharmaceutical manufacturing team by directing daily manufacturing activities, training and developing employees to deliver quality products, reviewing production records, validation protocols and administering standard operating procedures. Experienced and trained in Root Cause Failure Analysis (RCFA). Used exceptional interpersonal communications, presentation and facilitation skills in daily activities to ensure that manufacturing operators perform to the highest possible standards. Demonstrated strong project management skills and success in leading cross-functional teams. Maintained quality control systems for assigned area including appropriate audits and associated corrective actions. Served on internal quality teams with regards to reviewing investigations, deviations, change controls, SOP’s and training modules.

Part of a team of engineers responsible for the commissioning and validation of new equipment, facility, packaging and critical utilities (HVAC, Electrical, Compressed Air, USP Water). Experience with Johnson Controls Metasys Building Management Systems. As a Certified Trainer I was responsible for training staff on new SOP's and Training Modules in accordance with FDA and cGMP guidelines. Performed time and motion studies. Monitored and measured manufacturing losses.

Created and executed IQ/OQ/PQ validation protocols with respect to: Packaging Equipment, Manufacturing Equipment, PLC validation, HVAC, Laboratory Equipment, Sterilizers, Autoclaves, Heating Ovens, Environmental Chambers, Critical Utilities and Facilities. Demonstrated ability to use regulatory knowledge to resolve quality and compliance issues with minimal guidance. Knowledgeable with the Kaye Validator 2000 and capable of calibrations for an array of monitoring equipment for temperature and humidity. Responsible for maintaining the Validation Services equipment Access database consisting of over 2000 documents.

Responsible for assisting engineers with carrying out multiple experiments and projects. Responsible for making sure orders were shipped to external clients on time and that all measurement data was correct and accurate. Demonstrated ability to maintain a constructive problem-solving attitude while dealing with time demands, incomplete information or unexpected events.

Masters, Business Administration

Activities and Societies: MBA Association Class President Norman Kaylor Most Outstanding MBA Student Award Recipient

Bachelor Of Science (Bs), Industrial Technology

Diploma