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
Virginia
01-2022
Certified Associate in Project Management (CAPM – PMI) -