LISA WALLWORK
Fairfax
Summary
Dynamic Senior Program Manager with expertise in FDA compliance, cross-functional leadership, and process optimization. Proven success in driving breakthrough projects within the Companion Diagnostics, Medical Device and Orthopedic industries, enhancing client relationships, and optimizing processes for strategic growth.
Overview
18
18
years of professional experience
Work History
Senior Program/Project Manager
Quest Diagnostics
01.2022 - Current
- Company Overview: Companion Diagnostics (CDx)- BioPharma Services
- Led cross-functional team within matrix organization to support key partner’s drug portfolio.
- Oversaw Companion Diagnostic (CDx) assay development for class 3 medical device, achieving FDA PMA approval and market release.
- Secured breakthrough device designation for first program within CDx division.
- Drove program through design control, adhering to ISO13485 and 21 CFR 820 standards.
- Supported development and implementation of regulatory strategy across US and global client portfolio.
- Facilitated cross-functional alignment and client communication during escalation periods.
- Presented innovative proposals to Executive Leadership, addressing critical customer challenges.
- Assisted Operations team with internal and external contract development; executed over 40 statements of work.
Project Manager
Thermo Fisher Scientific
Middletown
01.2020 - 01.2022
- Company Overview: Clinical Diagnostic Division
- Led cross-functional teams in operations, quality, finance, and supply chain for process improvement projects totaling $1M-$25M.
- Prepared and presented reports to leadership, facilitating data-driven decision-making for strategic growth.
- Served as primary contact for customers, managing full lifecycle projects to FDA-approved transfer of finished goods.
- Contributed to development and implementation of Project Management Office (PMO) to promote operational excellence and standardization.
Senior Associate
CORTAC Group
Rolling Hills Estate
01.2018 - 01.2020
- Produced targeted organizational proposals to meet federal healthcare client requirements.
- Conducted comprehensive technical writing and research to support executive leadership objectives.
- Acknowledged by senior staff as a model for data collection and proposal presentation.
Assistant Office Manager
United States Department of State
Warsaw
01.2016 - 01.2018
- Company Overview: United States Embassy
- Worked alongside the Economic Counselor and Deputy Economic Counselor to ensure smooth processes within the US Embassy.
- Coordinated, organized, and planned strategic meetings with Polish foreign nationals and senior executive staff members; developed an internal communication system to track meeting times, locations, and attendees.
- Interviewed foreign nationals and documented US relations within Poland; provided timely reports to US diplomats to allow US decision-makers to structure US policy.
- United States Embassy
Director of Durable Medical Equipment
Ortho Virginia
Fairfax
01.2008 - 01.2015
- Increased net profit by 35% over seven years through effective budget governance and program enhancements.
- Implemented DME ancillary revenue stream for a 35-member practice while leading training for 150 clinicians annually.
- Managed a team of DME coordinators focused on patient education regarding various medical devices.
- Developed four new service line programs from comprehensive market analysis, including retail DME offerings.
- Conceptualized and implemented standardized surgical protocols, securing 95% commitment from physicians for improved workflow.
- Coordinated medical equipment supply chain management with less than 1% product shrinkage via strict audits.
- Facilitated a national DME summit to foster collaboration among practices for process improvement initiatives.
- Enhanced patient and physician compliance while decreasing product waste across all operations.
Education
Lean Six Sigma Green Belt
Thermo Fisher Scientific
Virginia01-2022
Certified Associate in Project Management (CAPM – PMI) -
Syracuse University
11.2020
Certified Mat Pilates Instructor -
Power Pilates
11.2011
Master of Arts - Managerial Economics
University of Oklahoma
01.2006
Bachelor of Science (B.S.) - Sports Medicine
Westfield State University
01.2002
Skills
- Cross-functional leadership
- Project management
- Process improvement and optimization
- FDA compliance
- Change management
- Client relationship management
- Strategic planning for growth
- Data analysis
- Business planning and development
- Contract negotiation
Websites
References
References available upon request.
Timeline
Senior Program/Project Manager
Quest Diagnostics
01.2022 - Current
Project Manager
Thermo Fisher Scientific
01.2020 - 01.2022
Senior Associate
CORTAC Group
01.2018 - 01.2020
Assistant Office Manager
United States Department of State
01.2016 - 01.2018
Director of Durable Medical Equipment
Ortho Virginia
01.2008 - 01.2015
Lean Six Sigma Green Belt
Thermo Fisher Scientific
Certified Associate in Project Management (CAPM – PMI) -
Syracuse University
Certified Mat Pilates Instructor -
Power Pilates
Master of Arts - Managerial Economics
University of Oklahoma
Bachelor of Science (B.S.) - Sports Medicine
Westfield State University
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