ProcellaRX is a Strategic Advisory firm and SaaS Application Management service provider. In this role I am driving our Global Compliance Strategy and Solutions. - Leading the development and implementation of comprehensive compliance strategies and solutions on a global scale. - Ensure that our operations, products, and services adhere to relevant regulatory requirements and industry standards. - Guide and mentor cross-functional teams, including sales, marketing, and technical departments, to foster a culture of compliance and drive strategic initiatives that align with our company’s mission and growth objectives. Leveraging my expertise in SDLC and CSV, I work closely with technical partners to ensure all collaborative projects meet compliance requirements, thereby fostering stronger and more reliable partnerships. This is essential for maintaining trust with our PRX customers and demonstrating our commitment to quality and regulatory adherence.My insights and leadership in compliance help align our company’s growth objectives with regulatory requirements, which is pivotal to enhancing PRX’s reputation, reducing risks, and driving strategic growth.

Providing Computer System Validation and Software Assurance services as a part of regulatory compliance for Life Sciences and Health Care companies with a focus on digital testing.

Providing guidance and support for Computer Systems Validation (CSV) activities with the Information Systems group.

Computer Systems Validation (CSV) Lead guiding business partners, Quality Assurance, and project teams for system delivery and ongoing support. As part of SDLC, I ensure compliance, training & documentation of federal, industry and internal organizational ISPE GAMP and PIC/S regulatory protocols, standards & process controls for Enterprise System Platforms, Automation Applications, Stand Alone Systems, Infrastructure, and Data Integrity validation.

Computerized System Validation (CSV) Lead for projects and enhancements while working closely with the respective organization to assist in making strategic choices. Projects include global enterprise solutions such as SAP, TrackWise, Success Factors, MES, and Argus in addition to local MES, Historian, BAS, and RAM. Projects include assessments/remediation activity for local SCADA, HMIs, and PLCs. Provide guidance and assistance to validation resources for CSV strategy and activities for IT, Laboratory, and Manufacturing Operations. Create and/or review CSV documentation prepared in accordance with company SOPs and applicable regulations following SDLC and GAMP 5 methodology of risk assessment, testing, and change management. Drive solutions and champion IT responsibility along with quality culture to gain and maintain QA trust. I maintain a reputation for unraveling issues and identifying solutions which lead to project successes.

As a Validation Lead, I provided GxP computer system validation guidance and technical writing support for large and complex IT projects by preparing and facilitating required CSV documentation for IT implementations with and without GxP impact.CSV documentation is prepared in accordance with company SOPs and applicable regulations following SDLC and GAMP 5 methodology of risk assessment, testing, and change management. Working in collaboration with IT project managers as a liaison to the Quality department, I assisted PMs in delivering validated systems for production use.

Provide high caliber and professional administrative support to global vice president and five directors as a liaison to the Information Technology DepartmentReview incoming correspondence, assigning priorities and drafting responses when appropriateSchedule and maintain international travel arrangements, including visa and passport processing for multiple nationalitiesMaintain contacts and calendars, coordinate meetings and facilitate resolution of schedule conflicts Screen incoming calls by assessing the needs of the caller and handling inquiries whenever possible to minimize interruptions to the management team Coordinate signature and document trackingArrange interview schedules and travel for prospective employees across the worldFacilitate on-boarding process for new employees and consultantsDraft insightful department wide communications, transcribe data and respond to various business correspondenceOrganize in-house and off-site meetings, events and luncheons for department of 65 employeesCoordinate multiple department meetings and events for up to 215 employeesCreate and update reports based on relevant information and special projects as assignedResponsible for procurement of office furniture, supplies, training materials and testing equipment Generate purchase orders, track and receive merchandise, and correspond with accounting department to guarantee invoices and expense requests are paid on timeSAP Time Administrator: Coordinate time reporting, time off requisitions, and paycheck distributions

Provided administrative support to Mylan IT department.