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Work Background
MedStart Compliance Services LLCPrincipal
Jan. 2023New Jersey, United States · RemoteHelping early stage (seed, A round) health care/health-tech/med-tech companies achieve HIPAA compliance and accelerate their cybersecurity program.
Vault HealthDirector, Information Security and Technology
Sep. 2020 - Sep. 2022
KPMG USDigital Nexus - Director, IT Compliance
May. 2016 - Jul. 2020Montvale, NJEstablish and lead an IT Compliance program ensuring all required policies, procedures and controls are established and executed in a manner which ensures compliance with applicable business, industry and regulatory mandates Partner with senior management to understand the strategic and tactical plans of the supported lines of business, business process groups and IT in order to develop firm wide IT compliance processes and plans that are aligned with the overall business and IT needs Collaborate with the other members of KPMG's Technology Group as wells as Risk Management, Internal Audit, Inspections, DPP, the NST, etc. to identify major risk factors; Develop and coordinate the implementation of practices to mitigate and remediate process, operational, regulatory and compliance risks Identify potential areas of compliance vulnerability and risk; develop/implement corrective action plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future Provide support and oversight to various IT audit projects and testing initiatives, including audits of internal controls; Promote firm wide culture change, training internal staff on the proper execution of the established compliance related process, procedures and controls Develop and maintain all IT compliance documentation, policies, procedures and controls; Promote the continuous improvement of these practices ensuring KPMG remains compliant with changing business, industry and regulatory requirements
Clearwater Compliance LLCVice President - Service Delivery
Apr. 2014 - Apr. 2016I was brought in by the leadership team to drive the growth and extend the service delivery capabilities of this healthcare security compliance consulting firm. As we have expanded nationally by delivering SaaS-based solutions, we now offer the following information security compliance services for the healthcare, pharmaceutical, and other highly regulated markets related to HIPAA, HITECH, SOX, and PCI: ► Risk Analysis & Risk Management ► Security & Privacy Solutions ► Breach Notification ► Compliance Consulting and Implementation ► Compliance Training Program Development & Delivery ____________________ HIGHLIGHTS TO DATE
____________________ ► Cultivated a focus for the practice on risk analysis and risk management that has positioned Clearwater as the premier information security and healthcare security services firm in the industry ► Created a comprehensive information security program, policies, and procedures ► Strengthened the service delivery framework to attain a Net Promoter Score (NPS) of 72, with 53 of 54 clients recommending
Johnson & JohnsonIT Manager/ISO
Jan. 2005 - Apr. 2014Raritan, NJI served in a series of technology and information security management roles across various groups within J&J over a 10-year period. For IT Risk Management, I assembled and led a niche team in information security operations and security standards compliance for the Global Supply Chain and Pharmaceutical R&D units. We conducted security analyses, risk, vulnerability, and threat assessments. ► Developed Cloud Services transition strategy (SaaS/IaaS/PaaS) that enabled the outsourcing of critical pharmaceutical activities to Cloud providers, namely: ---Drug Safety Program ---Clinical Trial Management Systems As the CISO for the Systems Engineering Group, I oversaw the global compliance function pertaining to the Information Asset Protection Policy affecting more than 9,000 staff across 22 locations. Together with my team of direct reports, we evaluated the IT posture of all vendors and partners and assessed the risk in each of our business systems. We prepared and presented performance optimization and risk mitigation strategies regarding information system security to the leadership teams. In addition, we led information security policy training programs for all staff globally. We also evaluated the security risks associated with new joint ventures, mergers and acquisitions. ► Developed functionality strategy for a global regulatory submissions system ► Created a central repository to enable search for all R&D, improving information asset protection compliance ► Streamlined the CISO review and approval process ► Revamped the business partner risk assessment framework ► Led the development of the Synchrony Shared Service platform for cross-enterprise submissions of adverse event filings and lab equipment work orders ► Expanded the regulatory compliance EDI platform For Benefit & Risk Management, I designed and built the pharmacovigilance application portfolio infrastructure platform that reduced the budget from $3M to just $400K.
First Consulting Group LLCSenior Manager
Sep. 2000 - Jan. 2005As a member of the Senior Technical Team, I supported the organization by examining the existing IT strategies, solution architecture, system development processes, and risk management framework. We designed, developed, and supported key applications for Fortune 50 global pharmaceuticals. These applications included solutions for regulatory reporting, drug safety, and surveillance. ► Optimized service delivery and change management processes using the ITIL framework ► Created a focus on developing solutions that improve efficiency and team productivity ► Drove strategies to secure long-term application support contract wins
Hurley Consulting Associates Ltd.Executive Director of Systems
Feb. 1999 - Sep. 2000Serving in a CIO/CTO-type role for a pharmaceutical CRO/consulting company, I oversaw all aspects of systems management, support, and service delivery to our consulting team. I crafted and communicated the technical vision, and I engaged the CEO and executive team to foster strategy buy-in and execution. I also led the firm’s Y2K compliance initiative. ► Directed the overhaul of the document management process ► Planned and developed the firm’s capability for electronic regulatory submissions ► Orchestrated projects to improve disaster recovery and business continuity
Metrica, incNetwork Manager
Jan. 1992 - Dec. 1999
Dee Howard coNetwork Manager/Systems Admin
Jan. 1990 - Dec. 1999
San Antonio SavingsSystems Analyst
Jan. 1987 - Dec. 1989
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