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• Provide review and approval of all contracts that have an IT component• Experience developing high performance teams within the IT Service model• Compliance knowledge with external facing websites that gather customer or patient data• Served as Chief of Staff to IT Senior VP/CIO• Assumed oversight of Business Continuity Program within Ultragenyx• Implemented IT Security Program (SOP's, Tools) with IT Infrastructure team• Implemented Data Integrity principles within IT and rolled out training to other functional areas.

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• Responsible for implementation of Good Data Integrity Practices with regards to Lab Instrumentation and Equipment• Responsible for LIMS System Quality Oversight

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• Member of Software Compliance Council that decides validation strategy and objectives for company• Interact directly with FDA, Corporate and other regulatory agencies from a software validation standpoint• Responsible for software vendor assessment program implementation

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• Directly responsible for ensuring all software validation activities are in compliance with local procedures, Corporate Guidance documents, and regulatory standards• Develop strategy and implementation testing criteria for all automated systems• Directly responsible for reducing total number of open change controls via Lean methodology and Visual Control Management• Directly responsible for rollout of Lean Strategies to facility in regards to Visual Management and A3 ownership• Responsible for recommending and implementing changes to improve processes, productivity, and quality via Kaizen events• Develop, implement, and communicate department metrics and reporting systems• Interact directly with client, FDA and other regulatory agencies from a software validation standpoint

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 Distributed Control Systems (DCS)• 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• Certified as Eastman Lead Quality Auditor• Perform global compliance audits per FDA QSIT approach including the routine assessment of all internal quality and manufacturing operations as well as external vendors• Responsible for conducting and tracking internal and external audits per company procedures• Responsible for ensuring implementation of corrective actions identified during internal and external audits and conducting follow-up assessments as needed• Responsible for auditing LIMS, CDS and Documentation systems for quality systems audit as well as use of system• Develop and conduct internal cGMP training classes for current and new employees and maintain the training system database (TEDS)• Use quality tools including root cause analysis to identify corrective and preventive actions• Work closely with the management team to identify and implement ongoing improvements to quality systems

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• Identified and implemented ways to increase the visibility of the QC systems support group• Develop strategy to become more involved in overall Labware module implementations and new technology development• Lead effort to migrate change control process from paper system to Trackwise• Implementation of HEAT to work in conjunction with the IT group to maximize effectiveness and efficiency of group. Also to decrease turnaround time for problems logged into system.• Team member of Sandoz Computer Systems Validation Committee (QC lab representative)

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• Identify areas for improvements within the department by incorporating automated tracking tools for Lab Support group to help track shift change over information and other job-related information.• Responsible for working with IT to redefine QC business ownership of administration roles and responsibilities in a rapidly changing environment.• Responsible for a more effective implementation/administration strategy while allowing QC to focus on strategic strengths.• Accomplished training goal of 100% for Lab Systems Support group.

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• Excellent understanding of Gap Analysis and Risk Assessment Documentation• Responsible for Self Initiated Training program• Responsible for Automated Certificate of Analysis Report• Excellent understanding of FDA requirements, Good Documentation Practices, and Specifications and Standard Operating Procedures, ISO9000, Good Laboratory Practices, Good Manufacturing Practices as related to Computer systems and system controls• Develop test cases and master validation plans for additional StarLIMS modules using Life Cycle approach• Responsible for StarLIMS (Oracle) Database Setup and configuration at all facilities• Responsible for Remote Micro Data Collection requirements and system prototype• Responsible for original StarLIMS CPA for Y2K of $450,000• Responsible for the comparison of IEEE standards concerning Computer Hardware and Networking Components against local SOP’s• Conducted department training on Networking Essentials