Sr Manager IT Compliance, Security & Change Control @ Valeant Pharmaceuticals
IT Compliance Consultant @ QPharma Corporation
Director IT Audit and Compliance @ Cephalon, Inc.
Results-oriented IT Audit and Compliance Executive with demonstrated success in IT Compliance, Computer Validation, IT audit and risk management planning and execution to support strategic IT and business objectives. Recognized for implementing compliance risk system standards, processes and initiatives that reduce regulatory impact, increase revenue and reduce costs. Proven track record of transforming IT Groups into a
Results-oriented IT Audit and Compliance Executive with demonstrated success in IT Compliance, Computer Validation, IT audit and risk management planning and execution to support strategic IT and business objectives. Recognized for implementing compliance risk system standards, processes and initiatives that reduce regulatory impact, increase revenue and reduce costs. Proven track record of transforming IT Groups into a high value, strategically focused organizations through my visionary leadership.
My experience is aligned with PMI, IIA and ISACA certification practices.
- IT Compliance
- Business Continuity/Disaster Recovery Planning
- Strategic IT Planning and Governance
- IT Audit and Risk Management
- FDA, PDMA and SEC regulations
- Computer System Validation/21 CFR Part 11
- SSAE16 Reviews
- Security Assessments
- Cross Functional Teams
- System Development and Support
- SDLC Methodology
- IT Quality Systems
- IT Governance
- Application, Vendor & Infrastructure Audits
- Cross Functional Teams
- FDA & PDMA Regulations
- Strategic Planning
- Leadership Qualities
Sr Manager IT Compliance, Security & Change Control @ 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. From May 2012 to Present (3 years 8 months) IT Compliance Consultant @ Provided leadership and guidance to Ironwood Pharmaceuticals (Boston, Mass.) in the areas of IT risk management, security and IT regulatory compliance.
• Worked with IT management in revamping their software development, security and computer validation standards.
• Played a compliance role in their Commercial Systems Architecture development and risk mitigation.
• Developed a Project Milestone Review checklist to make sure that all key deliverables were verified and met key business requirements.
• Developed a strategic assessment and process improvement framework to evaluate IT’s processes, security controls and risk impact. From November 2011 to February 2012 (4 months) Director IT Audit and Compliance @ Provided leadership and project direction to 10 Auditors, Analysts, and Vendors in resolving system risk and compliance issues impacted by security and regulatory requirements. Responsible for global audit and risk initiatives (Security, BCP, and DRP) related to corporate and regional IT Operations, information systems, IT risk management, and IT regulatory compliance. Formulated an IT risk strategy to improve processes (i.e. Data Integrity, Data Security, System/Data Recovery), system development practices and adherence to regulatory compliance.
• Worked with IT management to develop and implement an enterprise risk strategy to monitor manage IT assets (Software & Hardware), security threats, data integrity.
• Worked with IT management in developing a 5 year strategy roadmap that included BCP/DRP, Security, 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. From March 2005 to October 2011 (6 years 8 months) Director, Global Information Technology (GIT) Compliance & Audits @ 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.). From February 2002 to March 2005 (3 years 2 months) Manager, Methods & Procedures @ Provided leadership and project direction to 4 employees in developing an IT compliance strategy and addressing IT regulatory issues. Responsible for developing computer validation & Part 11 standards that comply with FDA GxP requirements and executing quality audits to ensure compliance of corporate validation policies and procedures.
• Improved their system implementation processes by working with their Technical Support Group in developing a Change Management System (i.e. Lotus Notes) that tracks and tests all defect and upgrade changes to their business applications prior to moving into production. As a result, eliminated implementation delays and cost over-runs.
• Improved their regulatory compliance initiatives by auditing manufacturing operations on a regular basis and enforcing all validation standards for IT and QA projects in a GxP environment.
• Improved their regulatory document control requirements by working with their technical services group in developing a Lotus Note Application, ‘DocuCenter’ for an online document repository of all IT regulatory documents, i.e. SAP system
• development, change management and project management documentation. From November 1985 to February 2002 (16 years 4 months)
MBA, Marketing @ St. John's University NY From 1971 to 1975 BA, Business Management @ Marist College From 1967 to 1971 Bob MBA is skilled in: Compliance, SOX, Auditing, IT Governance, Sarbanes-Oxley Act, Process Improvement, Risk Management, IT Management, Computer System Validation, GxP, 21 CFR Part 11, Change Control, Validation, Pharmaceutical Industry, FDA
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