Carol Finnie Email & Phone Number

Rockville, Md

Summit, Nj

Quality, Data Integrity, Process Improvement, Audits, Correction Action (CAPAs and DEVs)As a Data Integrity Champion, represented IT on Global and Local Data Integrity initiatives. Performed gap assessments for site wide GMP instrumentation and enterprise systems that resulted in an increase in data integrity compliancy by over 50%. Liaised with cross functional teamDefended IT departmental processes to outside agencies (FDA, QA, Lachman), while performing many continual process improvement activitiesDeveloped and led the Periodic Monitoring Review process of over 400 standalone and enterprise lab systems. Efforts led to over 20 process improvements in the IT and scientific departments and ensured that systems were maintained in their original validated states.

Summit, Nj

Project managed a global enterprise scientific asset management (Blue Mountain RAM), Electronic Notebook (e-notebook) and Waters EMPOWER systems that resulted in simplified work flows, asset centralization, upgrading of instruments and software. Responsible for creating, planning, and execution. Ensured that project meet deadlines by allocating resources or re-prioritizing tasks so that the overall goal is accomplished. Analyzed business processes and customer needs; develop technology and business solutions utilizing various process improvement tools. Lead implementations for improved customer service, improved quality, reduced cost and waste, and continuous improvementResponsible for an IT lab support team of 8+. Transformed the IT lab ops (ITLO) group into a business aligned, client-focused organization. ITLO department supported Research and Development, Global Pharmaceutical Development, CAR-T, Biologics, and Manufacturing organizations.Focused on improved customer service, improved quality continuous improvement, and root cause analysis. Proactively anticipated issues and developed corrective actions for Enterprise and over 400 GMP Stand Alone lab Computer Systems.Successfully transitioned outsourcing model to managed services by reviewing Statement of Works (SOWs), Service Design, Transition Plans, KPIs, SLAs. Rapidly identified and course corrected opened CAPA and Deviations when applicable.

Designed and built newly formed lab systems engineering department. Individually completed recruitment, negotiation, hiring of staff and contractors. Evolved services into a truly integrated, enterprise level offering, suitable for growing biotech company. Ensured alignment of site resources with IT and business strategy. Won approval for a $250K project to inventory scientific instrumentation and workstations. Remediated over 500 instrument workstations so that they comply to company standards. Achieved project deliverable timelines and spending through effective budget and resource management, planning, scheduling, tracking and reporting of project tasks and activities.Ensured quality by promoting and adhering to company methodology, project management best practices, compliance and security requirements. Contributed to Installation Qualification of GxP systems. Supported internal GxP Audits, resolved issues, opened change controls. Performed external software audit with Quality Audit group.Developed continuous improvement of support processes that decreased scientific down-time and increased consistency, quality, and overall customer satisfaction. Expertise in analyzing business processes and creating Best Practices solutions. Manager/individual contributor with laboratory systems experience interfacing and managing technical and non-technical professionals, motivating teams and meeting budgetary requirements and implementation timelines.

Bridgewater, Nj

Responsible for many facets of IS department with regional and global customers.Major accomplishments include:• Drove IT North American R&D Lab Equipment Maintenance consolidation project of over 5000 scientific instruments that resulted in $2MM annual reduction in spending.• Actively involved in project lifecycle, which included vendor selection, contract negotiation, SOW, writing RFPs, performing site audits, leading monthly IT meetings, and evaluation of instrument inventory and service coverage. Created and conducted surveys and interviews, defined and measured key performance indicators, and presenting results to leadership teams.

Bridgewater, Nj

Managed several internal projects concurrently, with business, Information Systems, and outside vendors. Interfaced with customers, various IT departments, and vendors on critical issues and projects pertaining to hardware, software, storage, and network needs.Major accomplishments include:• Managed the integrations of third party applications into the lab services environment. Coordinated efforts to ensure uninterrupted scientific research time by maintaining over 120 lab instruments workstations with up-to-date virus protection and service pack updates.• Served as a lab expert lead on global and regional teams to identify lab workstation gaps, root cause and support corrective action• Worked within sanofi standards, best practices, and regulated environments to design, to test, implement, document, and validate computerized systems • Assured comprehensive GxP and IS compliance oversight and governance by performing site audits, preventative maintenance, writing IQs, OQs, SOPs, initialized and approved change controls• Diagnosed regional issues and made recommendations for improving work flow efficiency including business processes and systems and mitigating risk• Interfaced with customers, various IT departments and vendors on critical issues and projects pertaining to hardware, software, storage and network needs. • Lead a team of 5 to support scientists through organizational realignments, including staff reductions and while receiving outstanding customer feedback

Mba, Computer Applicaitons

Bs, Biology And Computer Science