Robert Kelly Mba Email & Phone Number

South Brunswick Township, Nj, Us

Bridgewater, New Jersey

Responsible for overall direction of all IT Compliance and Security functions associated with Information Technology applications, communications, computing services and infrastructure within the enterprise.Key interface with both internal and external audit teams, compliance, risk and business areas of the organization in an effort to architect and formulate secure business solutions and infrastructure. Manages the Corporate Computer Validation role and works with outsourced security teams to ensure policies and procedures are implemented and adhered to. Responsible for change control process and adherence to the process to meet SOX, GMP, and ITIL regulations and good business practices.

Morristown, Nj

Responsible for planning, establishing, and enforcing audit, compliance and process standards for Pharmaceutical Organizations.

Frazer, Pa

Provided leadership and project direction to 10 Auditors, Analysts, and Vendors in resolving system risk and compliance issues impacted by regulatory requirements. Responsible for global audit and risk initiatives (BCP, DRP) related to corporate and regional Data Centers, information systems, IT risk management, and IT regulatory compliance. Formulated overall IT risk strategy to improve processes, system development and adherence to regulatory compliance.• Worked with IT management in developing a 5 year strategy roadmap that included BCP/DRP, IT Governance, metrics and reporting which reduced the cost of system development and on-going maintenance.• Improved the company’s IT regulatory commitments by serving as an advisor to all levels of management and providing guidance, training and performance of periodic audits of compliance, security and regulatory issues.• Improved security controls over the internet, intranet and PC environments, and minimized hacker intrusion by performing regular security assessments of the company’s global infrastructure.• Reduced the annual SOX consultant budget by $500,000 as a result of improved processes and enhanced employee SOX training.• Improved the quality of data used by management for reporting purposes by executing audits of key systems (i.e. SAP, Track wise, Third Party Vendors) and providing system improvements for collecting accurate information.• Improved control over regulatory documents (Policies, SOPs, WIs, etc.) by implementing document management systems (i.e. Documentum, QDocs) that support regulatory/business activities.

Kenilworth, Nj

Provided leadership and project direction to 7 employees and 8 consultants in addressing IT compliance issues with Corporate Compliance and the FDA. Responsible for Computer Validation and CFR Part 11 initiatives, change management processes, and document management controls. Planned and administered annual operating budgets of $2 million and capital budgets of $12 million. • Reduced the risk of IT non-compliance with the FDA and SEC by establishing a Compliance & Audit Unit for the Global Information Technology Group and provided leadership to a group of qualified technical & validation professionals.• Met the requirements of a FDA consent decree by managing the validation effort in completing approximately 700 device qualifications & 20 support applications.• Met corporate management’s IT infrastructure strategy by managing a project team that successfully transferred & validated the mainframe systems from SP’s Memphis facility to IBM (Southbury, Conn.).

Iselin, Nj

Was responsible for: • Developing computer validation & Part 11 standards that comply with FDA GxP requirements.• Validation & Part 11 training of all Process & Project Managers assigned to FDA compliance.• Maintaining the corporate Software Master Validation Plan.• Reviewing and approving of validation protocols & results.• Establishing an internal audit program to ensure compliance to corporate validation policies & procedures.• Reviewing and approving of all Subcontractor application development/testing including user acceptance testing.• Auditing manufacturing operations and managing IT/QA projects in a GxP environment for FDA compliance.

Mba, Marketing And Computer Science

Ba, Business Management

Activities and Societies: Football Team