Tunde Afolabi
Johnston
Summary
As a seasoned IT leader with extensive experience in the pharmaceutical industry, I specialize in aligning technology strategy with business objectives. I possess expertise in IT enterprise architecture, computer system validation, quality system implementation and administration, data management, cybersecurity, data integrity, and GxP compliance. I focus on ensuring that IT systems are scalable, secure, and compliant with FDA, EMA, and other relevant regulatory regulations. I am adept at leading small- and large-scale IT implementations, managing IT projects, and collaborating cross-functionally with research and development (R&D), quality assurance, clinical teams, and regulatory affairs.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Associate Director IT Business Partner - GxP and R&D Operations
Celldex Therapeutics
07.2023 - Current
- Overseeing the GxP and R&D IT portfolio to ensure compliance with regulatory standards
- Serve as the IT owner for all relevant functional systems and collaborate with the owners of these systems to evolve the support model based on user needs and the overall IT strategy.
- Overseeing the implementation and validation of clinical and regulatory systems to support Phase III clinical studies
- Coordinating all IT projects related to GxP and R&D, including the implementation, upgrade, update, and enhancement of new systems
- Supervising IT consultants and system service providers
- Updating IT policies, procedures, and standards to maintain regulatory compliance
- Collaborating with a cross-functional team of internal stakeholders, IT consultants, and software vendors to recommend new purchases, upgrades, or updates to software while resolving system issues
- This includes maintaining the validated state of computerized systems and ensuring data integrity
- Supervising all compliance activities related to GxP operations, including change control, audit trail review, IT system periodic review, deviations, and other quality programs.
- Implementing data mapping or flow for all GxP and R&D to ensure data is consistent, original and available.
- Serve as a resource for end users by addressing technical issues, implementing necessary configuration changes through change management, and carrying out system administration tasks as required.
Manager IT Operations, Computer System Validation and IT Infrastructure Qualification
Rentschler Biopharma
01.2023 - 07.2023
- Managed multiple IT projects, including the implementation of new systems, as well as upgrades, updates, and enhancements
- Led, developed, and maintained validation and compliance activities within the GxP area, which involved audit trail review, periodic review, change management and Deviation
- Served as a system administrator for several GxP systems
- Collaborated with the IT team in Germany to develop and implement data integrity programs, policies, procedures, and training for business process owners and end users
Manager, IT Business Partner GxP, and R&D Operations
Acceleron/Merck Pharma
06.2020 - 10.2022
- Acted as the IT business partner for Veeva Vaults and BRAM and other GxP and R&D systems implementation, configuration, validation, and maintenance
- Established a retrospective validation program and quality tools to validate and maintained all GMP systems currently in production.
- Collaborated closely with the Quality Assurance Validation team, Business Process Owner, an IT to ensure the maintenance of all compliance programs for GxP systems, including periodic review, audit trail review, user management review, vendor management, and data integrity
- Evaluated and managed system upgrades, patches and new releases by assessing the impact and the risks on the existing configuration and validation processes
- Worked with the Merck IT team to facilitate the transfer of data and systems from Acceleron to Merck following the acquisition
- Managed cross-functional teams to deliver high-quality projects on time and within budget.
Senior Software Engineer/Professional Services
Waters Corporation
02.2017 - 07.2020
- Conducted software testing and configuration for Water Customers
- Provided phone support for Waters applications and instruments to customers
- Served as a Waters Field Service Engineer, visiting customer sites to install and troubleshoot Waters software and instruments
- Delivered professional services, including software validation and testing, for Waters customers
- Provided software and other technical training to customers, as required
- Enhanced software functionality by identifying and resolving complex technical issues.
- Maintained comprehensive documentation of development work, facilitating knowledge sharing among team members.
Lead IT, GxP R&D Operations
Immunogen Inc
10.2013 - 10.2016
- Responsible for the overall development, implementation, maintenance, and monitoring of quality control IT systems and analytical instruments
- Led a cross-functional team to successfully implement LabWare LIMS across the site
- Authored, reviewed, and approved computer system validation deliverables and 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 IT Infrastructure and Applications Support
Lonza Biologic
02.2008 - 10.2013
- Supported implementation of IT infrastructure and computer systems
- Provided end-user support for IT and laboratory systems, including 24/7 helpdesk support for software and hardware
- Worked with validation and business team to authored, reviewed, and approved validation documentation
- Managed IT Active Directory, antivirus program, computer and server setup, Network monitoring and security
- Performed system upgrades, patches, and enhancement
- 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
- Managed vendor relationships to negotiate cost-effective service contracts and obtain the best possible pricing on equipment purchases.
- Enhanced network security through the deployment of advanced firewall configurations and intrusion prevention systems.
- Mentored junior IT support engineers, fostering a collaborative environment that promoted professional growth and skill development.
IT Support and System Administration
Amgen Rhode Island
05.2005 - 10.2007
- Provided end-user and laboratory systems support, including 24/7 helpdesk support for software and IT Infrastructure
- Managed inventory of computer equipment, standardizing hardware configurations for ease of maintenance and scalability.
- Installed, configured, tested and maintained operating systems, application software, and system management tools.
- Optimized system performance, conducting routine checks and addressing potential issues before escalation.
- Maintained detailed documentation of technical issues, resolutions, and knowledge base articles for future reference.
Information Technology Help Desk Support
Rhode Island Analytical Laboratory
02.2003 - 05.2005
- Provided Tier 1 IT support to non-technical internal users through desk side support services.
- Used ticketing systems to manage and process support actions and requests.
- Maintained detailed documentation of all help desk interactions for future reference and analysis.
- Provided basic end-user troubleshooting and desktop support.
- Assisted in training new help desk staff, sharing best practices and technical knowledge for improved service quality.
- Enhanced customer satisfaction by resolving technical issues promptly and accurately.
Education
Certificate - Project Management
Bryant University
Smithfield, RIMaster of Science - Information Technology (Software Application Development)
Southern New Hampshire University
Manchester, NHSkills
- Computer Systems Validation and Assurance
- Quality compliance & GxP Systems
- IT Infrastructure Qualification
- Cyber Security
- Vendor/ Managed Service Provider Management
- Stakeholder Engagement
- Quality oversight including IT system audit trail and periodic review
- Project Management
- IT operations
- Data management and Integrity
- Proficient in systems including Veeva Vault QMS, eTMF, RIM, ERP, BRAM, CRM, LIMS, SAS, CDS, DocuSign, Trackwise, MasterControl, ELN, and Change Management
Certification
- Certified Scrum Master (CSM)
- Project Management Professional (PMP)
Timeline
Associate Director IT Business Partner - GxP and R&D Operations
Celldex Therapeutics
07.2023 - Current
Manager IT Operations, Computer System Validation and IT Infrastructure Qualification
Rentschler Biopharma
01.2023 - 07.2023
Manager, IT Business Partner GxP, and R&D Operations
Acceleron/Merck Pharma
06.2020 - 10.2022
Senior Software Engineer/Professional Services
Waters Corporation
02.2017 - 07.2020
Lead IT, GxP R&D Operations
Immunogen Inc
10.2013 - 10.2016
Senior IT Infrastructure and Applications Support
Lonza Biologic
02.2008 - 10.2013
IT Support and System Administration
Amgen Rhode Island
05.2005 - 10.2007
Information Technology Help Desk Support
Rhode Island Analytical Laboratory
02.2003 - 05.2005
Master of Science - Information Technology (Software Application Development)
Southern New Hampshire University
Certificate - Project Management
Bryant University
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