Ryan Denny Email & Phone Number

Vers-chez-les-Blanc, Vaud, CH

∙ Directly responsible for all IT service support within the GxP service of NHSc. This includes Quality, Clinical Operations, Mfg and Supply, Infrastructure and Compliance. ∙Manage $18MM budget and 18+ staff to support IT Service model for GxP within NHSc

Brisbane, CA, US

∙ Chief of staff to SVP of IT ∙ Worked with SVP to implement and refine the ITIL service model to support business functions (R&D, Quality, Mfg and Supply, Clinical Operations, Infrastructure)∙Responsible for implementation of PMO program within IT∙Responsible for IT Compliance service∙Support global IT functions as required

Novato, California, US

Novato, California, US

Responsible for all facets of IT Operations from supporting the implementation of a Gene Therapy mfg plant, Infrastructure / security strategy, PMO, budgeting and service model improvements.

Novato, California, US

• Currently responsible for all facets of IT compliance, IT Service Management, IT Budgeting (26M), Vendor management and resourcing initiatives.
• Implement strategic improvements to the IT Service model to allow maximum support of the business functions including (QA, R&D, Commercial, HR, Data Management, IT Operations.
• Lead effort with each IT Service Owner to implement process improvements and compliance initiatives as it relates to Cybersecurity, DLP, GDPR and CCPA.
• Lead effort with the SVP of IT/CIO to implement new technologies and develop applications to meet Ultragenyx initiatives.
• Set direction within IT for all aspects of IT Compliance and Risk.
• Utilize current technology for collaboration

Novato, California, US

• Directly responsible for SDLC / CSV / IT Compliance program implementation
• Implementation of IT Change Control process
• Provide direction within IT and Clinical with regards to CSV, Data Integrity
• Manage CSV vendors and SaaS / IaaS vendors
• Conduct CSV training and overall good practices per GAMP 5 and ITIL standards to IT staff and key IT vendors

Carlsbad, California, US

• Development of road maps for implementation of systems and processes to support GxP lab.
• Built strong relationships with IT organization for compliance based initiatives.
• Responsible for alignment of Genoptix CSV strategy with Novartis policies and procedures
• Responsible for implementation of Information Governance model within QA/IT
• Implementation of Computerized System Validation Methodology, VMP and Change Management for Computerized Systems
• Primary contact for FDA, Internal/External auditors as it relates to CSV

Abbott Park, Illinois, US

• Divisional responsibility to ensure all non-product software systems are complaint with internal and external regulatory requirements and Corporate Guidance documents
• Divisional oversight of software validation methodology and practices
• Responsible for development, review and approval of all software validation policies and procedures
• Manage and prioritize resources including headcount and department budget to meet and exceed project goals
• Set direction for AMO Software Development Life Cycle strategy
• Develop strategy and implementation testing criteria for all automated systems

Deerfield, Illinois, US

• Overall knowledge of Corporate Business Strategy. Establish internal team goals to meet those objectives
• Ensure continuous improvement of projects by improving standards, reducing project timelines, and managing staff to meet facility objectives
• Manage and prioritize resources including headcount and department budget to meet and exceed project goals
• Set direction for overall Software Validation and 21 CFR Part 11 program which includes Business and Quality Systems as well as PLC and SCADA based systems.
• Lead, coach, develop, and mentor a professional team of Business Systems Analysts
• Responsible for reviewing and approving all software validation related documentation

Kingsport, Tennessee, US

• Quality oversight for all software applications
• Responsible for developing and implementing Master Validation Plans, Test Cases and associated validation documentation for Chromatography Data System (CDS), Laboratory Information Management System (LIMS), and.
• Maintain validation documents and technical reports within LiveLink
• Responsible for ensuring all software validation activities are current per local SOP's and cGMP's
• Leading effort for developing user requirements for CDS, LIMS and Instrument Calibration systems
• Responsible for implementing standard operating procedures to ensure compliance with cGMPs

Basel, Basel-Stadt, CH

• Oversee daily activities within the Lab Systems Support group – 4 employees
• Responsible for employee performance evaluations and development plans
• Assumed responsibilities for allocating resources within the Lab Systems Support Group to assist with the implementation of the Chromatography Data System project.
• Conduct periodic meetings with peers to discuss new ideas and any processes that can be improved or developed - Team member of QC/IT Strategy development team
• Foster a positive team environment within Lab Systems Support group by use of personal skill set to motivate, encourage and lead group into a successful development plan as well as individual development.
• Established a relationship with IT to help further communication and reflect a more positive culture

Basel, Basel-Stadt, CH

• Assumed lead role for QC in administration and use of cGMP computerized systems within the quality control group
• Direct the implementation of automated tracking tools for change control for use within the Lab Systems Support group. Become key point of contact for all CSQA and Part 11 activities for the QC group.
• Managed the development of Raw Material requirements for Labware
• Lead effort to help identify user requirements for Labware Calibration and PM data collection for the Instruments group
• Lead the effort with QC training department to create and maintain a training program from a Lab Systems computer perspective for all QC personnel and new hires within the QC department
• Created visibility to Labware users for central point of contact for support for QC systems

Deerfield, Illinois, US

• Responsible for maintaining/tracking StarLIMS divisional upgrades CPA $697,000
• Responsible for validation plans and application development for LIMS modules
• Project leader for Paperless Calibrations System and LIMS Data Export
• International StarLIMS Divisional DBA and Network Administrator
• Responsible for 21 CFR Part 11 Compliance program for laboratories and manufacturing
• Work in conjunction with IT department for setup and configuration of hardware/software for Quality based systems