Tunde Afolabi
Johnston,USA
Summary
As a seasoned IT GxP leader with extensive experience in the pharmaceutical industry, I excel in managing GxP and R&D IT systems, ensuring regulatory compliance and driving significant improvements in system validation and project management. My expertise spans across Computer Systems Validation (CSV) and cross-functional leadership, demonstrating a strong ability to enhance system integrity and operational efficiency.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Associate Director IT, GxP and R&D, Systems
CELLDex Therapeutics
Fall River, MA
07.2023 - Current
- Managing GxP and R&D IT systems portfolio to ensure regulatory compliance.
- Managing implementation validation of GCP systems to support phase three clinical study.
- Updating IT policies, procedures, and standards to ensure regulatory compliance.
- Leading and driving all the GxP system changes through a change management process.
- Leading and driving all validation programs, which include generating, reviewing, and approving validation deliverables.
- Collaborating with the cross-functional team of internal stakeholders, IT consultants, and software vendors to recommend new purchases, upgrades, or updates to software, and resolve system issues while maintaining a validated state of computerized systems and data integrity.
- Overseeing all system compliance activities, such as change control, deviation, and effectiveness checks.
Manager, IT Computer System Validation
Rentschler Biopharma
Milford, MA
01.2023 - 07.2023
- Managed multiple IT GxP projects, including new system implementation and enhancements.
- Led, developed, and maintained validation and compliance activities across the supported GxP system, including authoring, reviewing, and approving validation deliverables.
- Executed the validation protocol and served as a system administrator for the GxP system.
- Developed and implemented data integrity programs, policies, procedures, and training for business process owners, or end users.
- Assisted with inspection readiness activities.
Manager, IT GxP Operation & Computer System Validation
Acceleron/Merck Pharma
Cambridge, MA
06.2020 - 10.2022
- Represented IT as a technical SME in cross-functional teams to investigate, analyze, design, implement, and maintain GxP applications.
- Oversew day-to-day GxP operation.
- Worked closely with the quality assurance validation team and the business process owner to maintain all compliance programs for GxP systems, including periodic review, audit trail review, user management review, vendor management, and data integrity.
- Managed the overall validation program for GMP (Quality Control and Manufacturing) systems, including generating system administration and operation procedures.
- Led all IT GxP system projects, including new system implementations and enhancements.
- Worked with Quality and Facility to implement Veeva Quality and BRAM applications.
- Acted as System Administrator/Owner for all GxP & R&D systems.
- Provided support for GxP regulatory inspections/audits as needed, including acting as a subject matter expert for GxP computer validation topics.
- Managed the upgrade and validation of SAS, IDBS ELN, and Empower CDS infrastructure for business.
Software Support Engineer/Professional Services
Waters Corporation
Milford, MA
02.2017 - 07.2020
- Provided phone support for Waters CDS applications and instruments to customers and Waters Service Engineers
- Analyzed issues to identify causes and develop corrective actions
- Re-created issues to determine the root cause of reported application behavior
- Followed through and completed outstanding issues, bringing tasks and projects to closure
- Performed installation, configuration, and qualification of Waters informatics and instrument products
- Documented support activities using Waters' Customer Interaction Tracking System (CIT)
- Engaged with external customers via remote control interfaces such as WebEx, TeamViewer, and GoToMeeting
- Troubleshoot software and computer networking for customers from personal workstations, workgroups, and enterprises
- Provided technical training to customers, as required
Lead IT, GxP Operation
Immunogen Inc
Norwood, MA
10.2013 - 10.2016
- Responsible for the overall development, implementation, maintenance, and monitoring of quality control IT systems, analytical instruments, and validation.
- Led a cross-functional team in the successful site-wide implementation of Labware LIMS.
- Authored, reviewed, and approved computer system validation deliverables.
- Participated in both internal and external audits.
- Provided end-user support and developed Standard Operating Procedures (SOPs) for software and equipment.
- Collaborated directly with Quality, Manufacturing, Vendor, and IT at all levels to meet project deliverables and timelines.
Senior GxP Applications Support Analyst
Lonza Biologic
Hopkinton, MA
02.2008 - 10.2013
- Supported implementation and enhancement of GxP systems.
- Provided end-user support for laboratory GxP systems, including 24/7 helpdesk support for software and hardware.
- Authored, reviewed, and approved validation documentation.
- Executed validation protocols and test scripts.
- Provided end-user training and developed Standard Operating Procedures (SOPs) for software and equipment.
- Participated in both internal and external audits.
Quality Control Associate
Amgen Rhode Island
Greenwich, RI
05.2005 - 10.2007
- Tested in process, drug substance, real-time sample, finished product, and stability sample.
- Provided QC laboratory operations, including software and equipment operations.
Education
Certificate - Project Management
Bryant University
Smithfield, RIMaster of Science - Information Technology (Software Application Development)
Southern New Hampshire University
Manchester, NHBachelor of Science - Applied Science
Federal University of Technology
NigeriaSkills
- Computer Systems Validation (CSV)
- Quality compliance & GxP Systems
- Impact and Risk Assessment
- IT infrastructure & Cyber Security
- System Assurance
- Vendor/ Managed Service Provider Management
- Project Management
- Change Management
- Continuous Improvements
- Inspection Readiness & Audits
- Cross-Functional
- Veeva, BRAM, LIMS, SAS, CDS, DocuSign, Trackwise, MasterControl, ELN, and laboratory instrument control applications
Certification
- Certified Scrum Master (CSM)
- Project Management Professional (PMP)
Timeline
Associate Director IT, GxP and R&D, Systems
CELLDex Therapeutics
07.2023 - Current
Manager, IT Computer System Validation
Rentschler Biopharma
01.2023 - 07.2023
Manager, IT GxP Operation & Computer System Validation
Acceleron/Merck Pharma
06.2020 - 10.2022
Software Support Engineer/Professional Services
Waters Corporation
02.2017 - 07.2020
Lead IT, GxP Operation
Immunogen Inc
10.2013 - 10.2016
Senior GxP Applications Support Analyst
Lonza Biologic
02.2008 - 10.2013
Quality Control Associate
Amgen Rhode Island
05.2005 - 10.2007
Certificate - Project Management
Bryant University
Master of Science - Information Technology (Software Application Development)
Southern New Hampshire University
Bachelor of Science - Applied Science
Federal University of Technology
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