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Kristen Wayne, CISSP
Cybersecurity Professional
Rockville, MD, United States
Details
Education:
MA
Latin American Studies
Georgetown University
2007 : 2009
Graduate Certificate
Cybersecurity
University of Maryland University College
2010 : 2011
BS
International Politics
Georgetown University
2000 : 2004
Richard Montgomery High School
Latin American Studies
Georgetown University
2007 : 2009
Graduate Certificate
Cybersecurity
University of Maryland University College
2010 : 2011
BS
International Politics
Georgetown University
2000 : 2004
Richard Montgomery High School
Experience:
Currently serves as the Director, Cybersecurity Risk Management and Compliance within the Office of Information Security (OIS) and as a member of the OIS Senior Leadership Team. Supervises and provides oversight of 26 FTEs, including audit, policy, and awareness personnel, Information System Security Officers (ISSOs), and ISSO Operations personnel, who support all FDA Centers, to include the field and FDA’s regulatory and scientific missions.
Directs the Division responsible for ensuring confidentiality, integrity, and availability of FDA’s systems and applications. Delivers mission first leadership and oversight of risk management efforts. Oversees the Division in the review and formal security evaluation of policies, procedures, designs, networks, systems, applications, configurations, and security controls for new and existing systems FDA-wide. Has served as acting Chief Information Security Officer (CISO).
Provides final review on products from across the Division, including policies, procedures, audit responses, Security Assessment Reports (SARs), waivers, risk acceptances, dashboards, and data call responses to the Department of Health and Human Services (HHS) and Department of Homeland Security (DHS), to include FISMA and HVA reports and assessments. Ensures mentorship to support staff development and supports recruitment and retention of top tier cyber talent.
Demonstrated ability to advise effectively on a wide range of cybersecurity compliance issues and to interpret policies, standards, and guidelines.
2022 : Present
FDA
Director, Cybersecurity Risk Management and Compliance
Served as the FDA ISSM and ISSO lead within OIS and as a member of the OIS Senior Leadership Team (beginning in September 2020). Supervised and provided oversight of 17 FTEs, including ISSOs and ISSO Operations personnel, who supported all FDA Centers, to include the field and FDA’s regulatory and scientific missions. Led the team responsible for ensuring confidentiality, integrity, and availability of FDA’s systems and applications. Directed the team in the review and formal security evaluation of policies, procedures, designs, networks, systems, applications, configurations, and security controls for new and existing systems FDA-wide. Served as acting FDA Compliance Division Director on numerous occasions, as well as acting Chief Information Security Officer (CISO).
Provided expert review on final products from across the Division, including policies, procedures, audit responses, Security Assessment Reports (SARs), waivers, risk acceptances, dashboards, and data call responses to the Department of Health and Human Services (HHS) and Department of Homeland Security (DHS), to include FISMA and HVA reports and assessments. Supported Binding Operational Directive (BOD) and Emergency Directive (ED) responses.
2017 : 2022
FDA
Information System Security Manager (ISSM) and Information System Security Officer (ISSO) Lead
Served as the FDA ISSO Operations Lead, managing 2 ISSO Operations FTEs. Helped support and lead a wide range of ISSO team activities. Liaised and facilitated communication with the FDA Privacy team, including representing the Information Security team on the FDA Privacy Council.
2016 : 2017
FDA
Information System Security Officer (ISSO) Operations Lead
Served as the Office of Information Management and Technology (OIMT) Information System Security Officer (ISSO) for the FDA Center for Drug Evaluation and Research (CDER) and the backup ISSO for the Center for Biologics Evaluation and Research (CBER). Cultivated and managed customer relationships to enhance communication and coordination and provided responsive service to internal and external customers.
2014 : 2016
FDA
Information System Security Officer (ISSO)
Supported tasks related to information assurance (IA)/information security/cyber security, privacy, IT systems security assessment, policy analysis and coordination, program oversight, and compliance.
- Used writing and analysis skills to contribute to IA, Public Key Infrastructure (PKI), policy, and privacy-related consulting projects and to provide support to both defense and civilian government agencies.
- IA and PKI experience included years of support to a federal CIO organization authoring, editing, coordinating, and implementing IA and PKI policies including those related to social networking and identity management, as well as Federal Information Security Management Act (FISMA) compliance and reporting.
- Developed and interpreted policies, procedures, and strategies governing the planning and delivery of IT services.
- Privacy experience included developing enterprise-wide privacy programs and policy; authoring compliance documentation; and authoring privacy training.
- Worked to facilitate discussions between different organizations in order to reach decisions on courses of action.
2008 : 2014
Booz Allen Hamilton
Associate
Directs the Division responsible for ensuring confidentiality, integrity, and availability of FDA’s systems and applications. Delivers mission first leadership and oversight of risk management efforts. Oversees the Division in the review and formal security evaluation of policies, procedures, designs, networks, systems, applications, configurations, and security controls for new and existing systems FDA-wide. Has served as acting Chief Information Security Officer (CISO).
Provides final review on products from across the Division, including policies, procedures, audit responses, Security Assessment Reports (SARs), waivers, risk acceptances, dashboards, and data call responses to the Department of Health and Human Services (HHS) and Department of Homeland Security (DHS), to include FISMA and HVA reports and assessments. Ensures mentorship to support staff development and supports recruitment and retention of top tier cyber talent.
Demonstrated ability to advise effectively on a wide range of cybersecurity compliance issues and to interpret policies, standards, and guidelines.
2022 : Present
FDA
Director, Cybersecurity Risk Management and Compliance
Served as the FDA ISSM and ISSO lead within OIS and as a member of the OIS Senior Leadership Team (beginning in September 2020). Supervised and provided oversight of 17 FTEs, including ISSOs and ISSO Operations personnel, who supported all FDA Centers, to include the field and FDA’s regulatory and scientific missions. Led the team responsible for ensuring confidentiality, integrity, and availability of FDA’s systems and applications. Directed the team in the review and formal security evaluation of policies, procedures, designs, networks, systems, applications, configurations, and security controls for new and existing systems FDA-wide. Served as acting FDA Compliance Division Director on numerous occasions, as well as acting Chief Information Security Officer (CISO).
Provided expert review on final products from across the Division, including policies, procedures, audit responses, Security Assessment Reports (SARs), waivers, risk acceptances, dashboards, and data call responses to the Department of Health and Human Services (HHS) and Department of Homeland Security (DHS), to include FISMA and HVA reports and assessments. Supported Binding Operational Directive (BOD) and Emergency Directive (ED) responses.
2017 : 2022
FDA
Information System Security Manager (ISSM) and Information System Security Officer (ISSO) Lead
Served as the FDA ISSO Operations Lead, managing 2 ISSO Operations FTEs. Helped support and lead a wide range of ISSO team activities. Liaised and facilitated communication with the FDA Privacy team, including representing the Information Security team on the FDA Privacy Council.
2016 : 2017
FDA
Information System Security Officer (ISSO) Operations Lead
Served as the Office of Information Management and Technology (OIMT) Information System Security Officer (ISSO) for the FDA Center for Drug Evaluation and Research (CDER) and the backup ISSO for the Center for Biologics Evaluation and Research (CBER). Cultivated and managed customer relationships to enhance communication and coordination and provided responsive service to internal and external customers.
2014 : 2016
FDA
Information System Security Officer (ISSO)
Supported tasks related to information assurance (IA)/information security/cyber security, privacy, IT systems security assessment, policy analysis and coordination, program oversight, and compliance.
- Used writing and analysis skills to contribute to IA, Public Key Infrastructure (PKI), policy, and privacy-related consulting projects and to provide support to both defense and civilian government agencies.
- IA and PKI experience included years of support to a federal CIO organization authoring, editing, coordinating, and implementing IA and PKI policies including those related to social networking and identity management, as well as Federal Information Security Management Act (FISMA) compliance and reporting.
- Developed and interpreted policies, procedures, and strategies governing the planning and delivery of IT services.
- Privacy experience included developing enterprise-wide privacy programs and policy; authoring compliance documentation; and authoring privacy training.
- Worked to facilitate discussions between different organizations in order to reach decisions on courses of action.
2008 : 2014
Booz Allen Hamilton
Associate
Company:
FDA
Years of Experience:
20
Spoken Language:
French, Spanish
Skills
Computer Security, Defense, DoD, Foreign Policy, Government, Information Assurance, International Relations, National Security, Policy
About
Over eighteen years of professional experience.
- Currently leads, mentors, and promotes the professional growth of a diverse, highly skilled, and qualified Cybersecurity Risk Management and Compliance workforce cadre that supports the Food and Drug Administration (FDA) public health mission.
- Has led teams at both FDA and Booz Allen, with a strong leadership background in compliance, information security/cybersecurity, policy analysis, and privacy.
- Well versed in federal cybersecurity mandates/guidance. Directs resolution of identified cybersecurity gaps and supervises responses to enterprise cybersecurity challenges by overseeing analysis and problem resolution.
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