Experience
Jessica L Kolling Consulting, San Francisco CA
Founder / Independent Consultant (May 2023 - Present)
SUMMARY: Encouraging digital health innovation and transformation by helping health technology startups create a compliance framework focused on patient protection, data privacy, and information security from inception to launch.
SERVICES OFFERED:
Compliance Strategy
Organizational Change Management
ISO 27001 Implementation Guidance / Program Management
Vanta Customization
ISMS/QMS Process Improvement and Implementation
Risk, Governance, and Compliance
Fractional / Interim Team Leadership
Process Improvement
Process Development
Betteromics, Redwood City CA
LEAD QUALITY ENGINEER (Jul 2022 - Mar 2023)
SUMMARY: Betteromics is creating a single platform to collect, process, and analyze life science data.
IMPACT:
Directed and executed compliance with key quality system standards (i.e. ISO 9001, ISO27001, Soc 2, Hitrust) and drove continuous improvement of company processes (e.g. SDLC, Change Management, Suppliers, CAPA, etc.) in support of the clinical product and security/infrastructure team at 50 person pre-series A organization.
Communicated with clients to ensure alignment with customer requirements, and adherence to SLAs.
Drove organizational change to streamline change control/release process decreasing execution time by 20% and enabling bi-weekly releases of the company’s validated clinical platform.
Executed technical program management for security/infrastructure team; implemented JIRA sprint planning, launched “Infra-On-Call”, and created strategic quarterly roadmap to increase productivity and reduce interrupts.
Supported audits for ISO 9001, ISO 27001, and Soc 2 resulting in certification.
Designed and led Betteromics first business continuity/disaster recovery workshop including both tabletop and functional exercise components.
Designed and launched JIRA reporting infrastructure to enable improved tracking of key quality metrics across the organization and easy escalation pathways for timely resolution of high-priority issues.
Authored and released procedures, architectural design documentation, and product requirements.
Evidation, San Mateo CA
Senior Manager, Quality Systems (Mar 2022 - JUL 2022)
Manager, Quality Systems (Feb 2020- Mar 2022)
Senior Quality Operations Lead, (Jan 2019- Jan 2020)
SUMMARY: Evidation Health is a new kind of health and measurement company that provides the world’s most innovative biopharma and healthcare companies the technology and guidance they need to understand how everyday behavior and health interact.
IMPACT:
Built and managed team of Quality Engineers responsible for GCP/ISO9001 quality system processes across 300 person organization.
Quality liaison for decentralized clinical trials with 21 CFR Part 11 compliance requirements; partnered with clinical research, product, engineering, and QA teams to lead planning, documentation, and execution of study validation activities and to provide subject matter expertise to address project issues.
Point-of-contact for clients in the event of quality-related issues to provide context, mitigation strategies, and proactive communication until issue resolution.
Developed strategic roadmap and led transition to an ISO9001 Quality Management System; managed project planning and execution of 20+ process and procedure updates across multiple functional groups, and 15+ contributors within 6 months.
Optimized processes to support scalable quality operations such as implementing a risk-based approach to complaint investigations resulting in a 33% decrease in open complaints within a single quarter.
Designed and launched a Quality metric reporting system for the executive leadership team to increase transparency, measure progress, and support data-driven decision-making.
Authored, released, and operationalized Evidation’s first Software Development Life Cycle, Risk Assessment and Change Control Procedures to enable FDA 21 CFR Part 11 compliance.
Coordinated strategic planning across various functions (Security, Privacy, Engineering, Legal, and IT) to ensure audit readiness.
The Centers for Disease Control and Prevention’s Geospatial Research Analysis and Services Program (GRASP), Atlanta GA
Senior Associate, DRT Strategies (2015-2019)
GIS/Public Health Analyst, HP Enterprise Services (2014-2015)
ORISE Fellow, Oak Ridge Institute for Science and Education (2013-2014)
SUMMARY: Reported directly to program director of the Geospatial Research, Analysis, and Services Program (GRASP). Provided consultation services including project coordination, product management, and spatial epidemiology.
The United States Cancer Statistics: Data Visualizations
Interactive mapping and data visualization application
Password: EBI4you!
Touchscreen application for the David J. Spencer CDC Museum exhibit: Places & Spaces Mapping Science (January 25- June 17, 2016)
IMPACT:
Managed relationships with 10+ internal and external partners; developed partner-specific project plans to improve interactive mapping websites, conduct spatial analysis, and produce publication-ready cartography.
Conceptualized, designed, and directed execution of the Beta version of the CDC’s Environmental Burden Index (EBI) - the first national estimate of environmental quality at the census-tract level.
Led cross-functional teams to define product requirements, milestones, deliverables, and software development strategy for a multi-year project to update the United States Cancer Statistics (USCS): Data Visualization website.
Led successful partnership with CDC’s Division of Cancer Prevention and Control resulting in increased funding to >1$M for 2019 fiscal year (2x fiscal 2018 budget).
Authored technical response for DRT Strategies solicitation resulting in a $42M/5 year contract with the CDC.
Coordinated design, development, and execution of technology projects with cross-functional teams comprised of research scientists, programmers, and designers.
Initiated adoption of JIRA Software into workflows, developed best practices, and presented internal training sessions.
Applied a semi-Agile/semi-waterfall approach to ensure rapid adaptability and customer engagement while meeting federal documentation requirements.
Produced cartography for the Emergency Operations Center in support of Polio eradication, Zika response, and the 2014-2016 Ebola outbreaks.
PUBLICATIONS & AWARDS:
Co-authored research paper: “County-level vulnerability assessment for rapid dissemination of HIV or HCV infection among persons who inject drugs, United States” published in the Journal of Acquired Immune Deficiency Syndrome (Nov 2016). Nominated for the 2017 Charles C.Shepard Science Award and the 2017 Statistical Science Award (received honorable mention). Analysis featured in the NY times.
Co-authored research paper: “Developing a granular scale environmental burden index (EBI) for diverse land cover types across the contiguous United States”, published in Science of The Total Environment (Sep 2022).
Received Best of Show/Best Cartography award (June 2017 ESRI Users Conference) for “The Environmental Burden Index: Estimating Environmental Quality by Peer Group” from among 900+ entrants.
“In a single word, Ms. Kolling is exceptional. In multiple words, she is a bright, accomplished, effective, and creative individual who leads by inspiration and example.”
Emory University Office of Sustainability Initiatives, Atlanta GA
“I have no doubt that Jessica will serve your institution well, and will make great change in our world someday.”
Program Assistant (2012-2013)
SUMMARY: Reported to the sustainability program coordinator. Provided research and program implementation support to OSI.
IMPACT:
Designed a system to streamline medical surplus equipment donation to MedSHARE by implementing audits, educating nurses, and strategically placing donation bins throughout Emory University Orthopedic and Spine Hospital.
Developed data acquistion and reporting process for 1) STARS/AASHE, 2) the Princeton Review, 3) the Sierra Club.
The Centers for Disease Control and Prevention’s Center for Environmental Health, Atlanta GA
Public Health Analyst (2012)
SUMMARY & IMPACT: Produced materials for a 3-course accredited associates-level disaster management curriculum (for small island states).
Emory University Rollins School of Public Health, Department of Global Health, Atlanta GA
Research ASSISTANT (2011-2012)
SUMMARY & IMPACT: Reviewed literature and organized data to support 3 concurrent grant applications to research m-health for diabetes prevention.
Global Growers, Atlanta GA
Education Coordinator (2011)
SUMMARY & IMPACT: Developed farmer training curriculum for local refugee population.
Jenifer Altman Foundation, San Francisco CA
Grant Administrator (2009-2010)
SUMMARY & IMPACT: Reported directly to the executive director. Provided administrative support for environmental health and social justice grant applications and general initiatives.
“Ms. Kolling’s ability to adeptly solve problems through critical reasoning and ‘think outside the box’ where appropriate, is chief among her strong suits.”
RRM Design Group, Oakland CA
Office Coordinator (2008-2009)
SUMMARY & IMPACT: Worked directly with the Principal. Managed facilities of the Oakland office and provided general administrative support to a staff of 20. Streamlined workflows to improve operational issues related to document production, logistics, space, and office relocation.
“She is not only intelligent but also shows imagination, self-confidence, willingness to accept responsibility, and superb problem solving capabilities”
Education
St Lawrence University
Canton NY
BS, Behavioral Neuroscience, Minor: Sociology (May 2004)
Study Abroad: Peru
Emory University, Rollins School of Public Health
Atlanta GA
MPH, Environmental Health (May 2013)
Thesis: A GIS Based Comparison of Three Social Vulnerability Indices Using Health and Exposure Data