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Work Background
IntraHealth InternationalLead International G2G Risk Assessment Advisor
Jul. 2024RemoteZambia LOCAL G2G Local Authority Risk Assessments (LARA) Provide expert risk management guidance to mitigate fiduciary risks of public finance management systems and mechanisms in support of USAID with the Ministry of Health in Zambia, Africa .
iHealthSyncChief Compliance Officer (interim)
Mar. 2024Austin, TX. Establishing GRC, data privacy, and cybersecurity division for iHealthSynch
Serving as the compliance SME for strategic planning and business development initiatives
TruvetaCompliance Manager
Oct. 2023 - May. 2024Bellevue, Washington, United StatesLead compliance manager for the implementation of an FDA regulatory grade data quality management system, with a focus on real-world data/real-world evidence provided by Truveta for use by multiple research divisions in pharmaceutical organizations for cohort studies.
CoalfireSr. Consultant
Oct. 2022 - Jul. 2023Colorado, United StatesSr. Consultant – Strategy/Cybersecurity, Privacy, Risk Management (SPR) practice - Co-author of Cybersecurity and Medical Devices article for international social media platform publication - Individual contributor to approach and methodology used for the Australian Infosec Registered Assessors Program (IRAP)
- Created and presented Cybersecurity Regulations and Issues for Medical Devices to multi-site
healthcare provider executive board as a thought leader for Coalfire
- Translated and delivered privacy regulations for Mexico and India for delivery to major client - Served as sales support subject matter expert to director of practice (domestic and international) - Conducted gap and risk assessment, auditing and reporting expertise for multiple SPR clients Conduct assessments and audits for entities needing to be compliant with security, cybersecurity, and privacy regulations, domestically and internationally.
GoldSky Cyber SecuritySenior Cyber Security Consultant
May. 2022 - Sep. 2022Tampa, Florida, United StatesContributor to the DREAM team at Gold Sky, GRC, Info/Cyber Security, Privacy specialist with emphasis on HITRUST engagements.
All Hands ConsultingCovid-19 Pandemic Recovery Planner for Baltimore City Health Department
Mar. 2021 - Aug. 2021Baltimore, Maryland, United StatesPerform all duties associated with recovery planning for the SARS CoV 2 pandemic as the incident recovery planner for the Baltimore City Health Department following FEMA guidelines and Incident Command Structure (ICS).
Rausch Advisory Services LLC.Project Team Lead
Mar. 2021 - Jun. 2021Atlanta Metropolitan AreaCurrently serving as the Audit Team Lead for the Atlanta Public Schools CoVid Readiness Audit, addressing virtual and face-to-face CoVid standards, requirements and expectations from federal, state and local public health guidance perspectives for the district.
Cyber Security Forum InitiativeProject Manager Team Lead
Jan. 2021 - Mar. 2021Maryland, United StatesServed as the Lead Project Manager for an international team [33 members] that developed a 10 hour course/product that addresses nine areas of Cyber and Non-Cyber Information Warfare from a US centric perspective for a variety of CSFI's audiences.
iPatientAxisSr. Principal Advisor (Strategic Advisement/Compliance (US and UK))
May. 2020 - Aug. 2023Rochester, New York Metropolitan AreaI served as the Sr. Advisor to the CEO regarding HIPAA implications (Privacy and Security) for this clinical research recruiting and medical data aggregation organization. I advised and contributed to iPatient Axis's strategic and tactical activities providing advisory guidance on issues associated with GDPR and Covid-19.
AmgenAmgen - Quality Deviation Investigator - Electro-Mechanical Drug Delivery Devices
Dec. 2019 - Dec. 2020Thousand Oaks, California, United StatesLead Complaints Compliance Gap Audit (21 CFR, Part 820.198 and 803)
· Created multiple Root Cause Analysis (RCA) technical reports for combination drug delivery, electro-mechanical devices using Ishikawa 5 Whys/Confirmed Causal Factors Methodologies · Lead for Data Verification on final RCA reports prior to them becoming effective
· Served as Ideation representative for complaints associated with biologics and drug delivery systems
· BioConnect/Salesforce (Post Market Complaints System), SAP Batch Trace Reports, VeevaVault/CDOCS and TrackWise Applications
Medical Engineering ConsultantsSr. HIPAA Consultant; Sr. Quality Management Systems Consultant
Sep. 2018 - Sep. 2019Alpharetta, GALead client's HIPAA Privacy/Security/EDI compliance initiative (All Assessment and Remediation Activities) Developed and created policies, procedures and accompanying collateral per 21 CFR, Part 820 for their quality management system - Boston Scientific Corporation Pathology Laboratory
NCC GroupSr. Security Consultant
Apr. 2018 - Aug. 2018New York, New York, United StatesConduct Info/Cyber security audits for various clients against NIST 53, ISO 27001 and GDPR. Perform Centers for Medicare and Medicaid Services audit for a healthcare insurance exchange organization
SAI GlobalSr. GRC Consultant, Information Security Risk Management
Jul. 2017 - Mar. 2018Alpharetta , GAConduct 3 party vendor information security risk management audits and assessments using Digital Manager 360 software developed by SAI Global
Centers for Disease Control and PreventionSr. Consultant - Audit Management - Office of the Chief Information Security Officer
Jan. 2017 - Jun. 2017Greater Atlanta Area
Centers for Disease Control and PreventionSr. Zika Response Health Communications Specialist
Nov. 2016 - Dec. 20161600 Clifton Road Atlanta, GA 30029
Centers For Disease Control and PreventionSenior Consultant/Contractor to NCIRD at the Centers For Disease Control and Prevention
Oct. 2015 - Oct. 2016AtlantaSenior Quality Management Specialist Consultant to the National Center for Immunization and Respiratory Diseases at the Centers For Disease Control and Prevention -Division of Bacterial Diseases (to include Meningitis subtypes A-C-W-Y, Haemophilus)
-Division of Microbial Pathogenesis and Immune Response ( Zika and Dengue)
-Division of Viral Diseases (to include Zika, Polio, Measles, Mumps, Rubella, Gastroenteric, Herpes)
Baxter InternationalLead CAPA Contractor/Sr. CAPA Consultant
Oct. 2014 - Apr. 2015Marion, North CarolinaRendered FDA CAPA remediation services to Baxter International
McKesson Health ITSr.Product Risk Management (Quality Management System)
Jan. 2012 - Dec. 2014Alpharetta, GA.Lead, created, developed and established the risk management process for one of their laboratory information system medical devices per the Food and Drug Administration (FDA) Regulation, 21CRF Part 820 using the International Standard Organization (ISO) 14971 approach and methodology.
Security Risk WatchSenior Director, Healthcare and National SPeaker
Apr. 2002 - Sep. 2002Annapolis, Maryland, United States● Provided development, content and marketing oversight for the ISO 17799 and NIST 800-53 based HIPAA-Watch™ product (to include compliance/HIPAA website content)
● Developed and manage Risk-Watch’s Certified Consultant Program ● Established and administered Risk-Watch’s healthcare strategic partners alliance program
● Served as Elected Steering Committee representative for the SHARP group; Business Processes sub-workgroup for WEDI/SNIP)
● Authored HIPAA/Healthcare/ related articles
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