Jim Ruddell Email & Phone Number

Strong focus on implementing risk based IT security and quality systems to comply with government and industry regulations by providing end to end support to meet business goals.

$30mm global consulting company with over 2000 employees.Responsible for overall Quality Assurance for a Managed Services group with multi-site data centers. Strong emphasis on realistic and efficient processes that work with business goals while maintaining compliance with several regulations. Provided expertise in risk and platform based infrastructure qualification and application validation for environmental systems, network, storage, servers, virtual environments, SharePoint (MOSS), RDBS and custom software. Defined policies and developed processes to meet FDA, PCI and ISO 9001 standards. Trained personnel on GxP basics and internal processes. Developed work instructions and test scripts with subject matter experts. Conducted periodic review, hosted all audit activity (average six per year) approved all changes as part of the Change Management process. Coordinated efforts across multiple business units to ensure compliance with standards and practices. Clients include industry leaders in accounting, food supply and pharma industries requiring a validated environment. Delivered a validated Change Management system using SharePoint technology, reduced time to process change requests and paperwork by 60%.Reduced qualified system delivery time by 75% through reusable component based qualification process.Developed several new processes - CAPA, Patch Management.Added flexibility, efficiency and reduced audit findings for existing processes (Training, Document Management, Configuration Management, Good Documentation Practices, and Incident Management.)Successfully attained SAS70 Type II reports for the past three years. Integrated off shore resources to qualification and training practices.Developed qualification and process to maintain the qualified state of virtual environments (a.k.a. "cloud" systems)Advised business units on risk based functional and technical design, test scripts and evidence requirements.

IT Security oversight in conjunction with Quality duties. Approver of physical and logical access to the data center, network and systems including access systems, firewalls, IDS, penetration testing and project security review. Set company acceptable use policy.Lead security risk assessments and mitigationAdvise network team on design goalsImplemented vulnerability scanning toolAdvise company on security policy, employee agreements and handbooks.Attained recertification of CISSP in 2010Infrastructure and Data Center Management, IT Support (2000 - 2008)Primary Architect, Administrator and Consultant for multiple hardware and software environments. Capacity planning, network configuration, documentation and ongoing maintenance and support. Responsible for maintaining SLAs in a 24x7 environment. Internal IT support of Active Directory, Exchange and SharePoint, managed the help desk and employee hardware / software implementation, backup and recovery.Saved company thousands of dollars in hardware costs by applying a risk-based approach to network design. Reduced notification of faulty hardware from up to 16 hours to five minutes.Used a $1000 software monitoring tool to create an enterprise-ready monitoring and alerting system.Developed a no-cost website to track and report customer Internet use, allowing accurate billing with open source technologies.; Lead integration of B&D's quality management system with BioMarin's to ensure compliance with shared support model. Participated on Change Approval Board for all customer changes.Attained recertification of CISSP in 2010Oversaw all qualification activities for ERP, LIMS and CMMS infrastructure.Host all customer audits | respond to audit reports | handle remediation effort.

Primary Architect, Administrator and Consultant for multiple hardware and software environments. Capacity planning, network configuration, documentation and ongoing maintenance and support. Responsible for maintaining SLAs in a 24x7 environment. Internal IT support of Active Directory, Exchange and SharePoint, managed the help desk and employee hardware / software implementation, backup and recovery.• Saved company thousands of dollars in hardware costs by applying a risk-based approach to network design. • Reduced notification of faulty hardware from up to 16 hours to five minutes.• Used a $1000 software monitoring tool to create an enterprise-ready monitoring and alerting system.• Developed a no-cost website to track and report customer Internet use, allowing accurate billing with open source technologies.

Programmer: Microsoft Visual Studio Technologies.

Software Developer - Visual Studio

Bachelor Of Science, Computer Science

Magna Cum Laude

Education record

Education record