As a member of the Senior Leadership Team reporting to the Chief Information Office (CIO), responsibilities include:• Leading IT/CSV teams at the Brantford, Ontario and Toluca, Mexico sites.• Serving as the primary liaison between the site IT/CSV teams and global Apotex Senior Leadership.• Collaborating with other senior leaders to establish strategic direction for the advancement and standardization of technology solutions across the global organization. • Serving as a senior leadership stakeholder/sponsor for site and global technical and compliance initiatives.• Ensuring global regulatory inspection readiness and providing support during inspections.• Road mapping system upgrades to mitigate operational and compliance risks of aging technology.• Leading global teams of IT/CSV professionals to evaluate, source, implement, validate and maintain GMP computerized systems in a state of compliance with internal policies/procedures, governing regulatory requirements, and guidance materials (e.g. ICH Q7, 21 CFR Part 11, Annex 11, PIC/S, MHRA, GAMP 5).• Providing project status updates to global Apotex Senior Leadership that include project delivery milestone and budget adherence, and escalation of constraints/risks with resolution options.• Working with Apotex Senior Leadership to make organization structure changes to adapt to evolving business needs and support business operational efficiencies.• Leading the transformation of legacy manual paper-based processes into more efficient electronic solutions.• Managing and reporting on site IT budgets including approval of OPEX and CAPEX expenditures.• Defining and overseeing cross functional fiscal year project initiatives at the site and global levels.• Establishing annual objectives, monitoring KPIs and conducting performance reviews of direct reports.• Overseeing and approving training and career development paths of global IT and CSV team members.

Reporting to the Global Information Systems (GIS) Director:• CSV/IT leadership responsibilities were expanded beyond the site Content Management system, GMP laboratory systems, and the global Enterprise Quality Management System (EQMS) to include GMP manufacturing systems (e.g. DeltaV, PLC/HMI based systems) and daily IT operations for the Brantford site.• Served as the primary liaison with Senior Leadership for IT and CSV initiatives.• Evaluated, sourced, implemented, validated, and maintained GMP computerized systems/applications in a state of compliance with governing regulatory requirements and internal policies/procedures.• Co-led the harmonization of CSV Programs between the Apotex Inc. and Apotex Pharmachem Inc. to enhance project delivery efficiencies, documentation consistency, and to enable leveraging vs. repeating.• Standardized technology with other sites to broaden technical knowledge expertise, advance troubleshooting capabilities, and enhance global team collaboration.• Established service desk reporting processes/practices and periodic review cycles to identify and address trends and systematic problems.• Managed and monitored the IT budget including approving OPEX and CAPEX expenditures.• Reviewed/approved CSV documentation, SOPs, change controls, deviation, investigations, CAPAs, etc.• Led GMP and non-GMP cross functional fiscal year project initiatives as assigned by senior management.• Supported internal and external audits and regulatory inspections.• Established annual objectives, monitored KPIs and conducted performance reviews of direct reports.• Coordinated and approved training and established career development paths of IT and CSV team members.

Reporting to the Global Information Systems (GIS) Director, as a co-manager of the Information Systems department at the Brantford site:• CSV leadership responsibilities were expanded beyond the site Content Management system to include GMP laboratory systems and the global Enterprise Quality Management System (EQMS).• Led CSV remediation activities for GMP laboratory systems within the AO/QC and R&D departments (e.g. Empower 3, LabX, IR, particle size, PXRD, NMR, ICP, UV-Vis, Elemental Analyzer, etc.).• Led the global implementation and validation of the TrackWise (EQMS) and embedded workflow applications at sites in Canada, Mexico, and India. Workflow applications included deviation, investigation, CAPA, effectiveness check, change control, and action items.• Served as the primary liaison with Senior Leadership for site specific and global CSV initiatives.• Reviewed and approved CSV documentation, SOPs, change controls, deviation, investigations, CAPAs, etc.• Led GMP cross functional fiscal year project initiatives as assigned by senior management.• Supported internal and external audits and regulatory inspections.• Established annual objectives, monitored KPIs and conducted performance reviews of direct reports.• Coordinated and approved training and established career development paths of CSV team members.

Reporting to the QA Validation Group Leader and then the Information Systems Manager, responsibilities included:• Established a comprehensive GAMP 5 based Computer System Validation Program that consisted of Standard Operating Procedures (SOPs) and document templates to bring consistency to CSV documentation and project delivery practices.• Instituted processes and practices to support the maintenance and regulatory compliance of validated GMP computerized systems/applications such as periodic reviews, mock data backup and restoration verifications, change management practices, system administration controls, etc.• Validated the Documentum DCM content management system that is inclusive of embedded workflow applications used for electronic authoring, review, approval, and training on GMP documentation.

US based consulting project at Eli Lilly (Indianapolis, IN):Reporting to the Manager of the Life Sciences division:• Served as the primary liaison between client, internal management, and project team.• Used I/O simulation software applications and testing environments to deliver projects on-time/under-budget.• Managed daily project operations including leading a team of up to 16 members, budget monitoring and adherence, and forecasting project delivery milestones.• Reviewed and approved CSV documentation for a wide variety of PLC/HMI based manufacturing and utility control systems (e.g. Water for Bulk Sterile Operations (WBSO), Water for Injection (WFI), Vial Washer/Depyrogenation Tunnel, Lyophilizers (Freeze Dryers), Vial Washer/Stopper, External Vial Washer, Vial Capper, Inspection Station, Tray Loader, Shrink Wrapper, Clean Steam Generator, Clean-in-Place (CIP), Autoclave, Parts Washer, and HVAC).• Ensured system and documentation changes were resolved through formal change control processes.

US based consulting projects at Pfizer (Kalamazoo, MI) & Perrigo (Allegan, MI):• Validated PLC/HMI based manufacturing control systems to meet regulatory requirements.• Developed system CSV documentation such as User/Functional Requirements, Design Specifications, Qualification Protocols, Trace Matrix, etc.• Coordinated system, documentation, and electrical drawing updates through formal change control practices.

• Testing of custom engineered electrical control systems prior to customer FAT and shipment.