About Me.
My consulting practice is built on 20 years of relevant experience as its solid foundation. I can confidently say that I have reached a point where I can offer my services as an SME and create a win-win situation for both you and me. My services are targeted to create efficiencies that address bottlenecks or sluggish quality processes.
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​FOCUS
Emerging biotech companies in Philadelphia
"Cellicon Valley" where I am based, as well as
consulting globally and across the U.S.
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EXPERIENCE
More than 20 years of experience in QA and QMS
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RESULTS
Proven and measurable results that
increase quality and performance
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​​​​My chemistry background has taught me to be analytical, organized, and results-driven. I am a board-certified chemist with a Master’s Degree in Organic Chemistry and years of Pharma and Biotech QA experience. I started working in the QC lab and worked my way through multiple roles in GMP commercial manufacturing before transitioning to academia to learn about cell and gene therapies. I consider myself an expert in understanding Quality Management Systems (QMS) and have a proven track record of leadership and problem-solving skills. I excel at turning “problems” into improvement projects. Who doesn't want things to be simple and efficient?
For detailed biographical information,
please visit my LinkedIn profile.​​
​​​Key Competencies/Skills:
​QMS Implementation
Developing/delivering Training Program/Content
Change Management Champion
Internal/External Auditing
3rd Party Management/CMO oversight
Strategic and Tactical Planning
Organizational and Negotiating Skills
QA Unit development – Building/optimizing teams, hiring staff
Manage Quality Remediation Projects​​
My Areas of Expertise
CELL AND GENE THERAPY​​
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Expertise: GMP Mfg, Sterile Mfg, Quality Operations, QMS, Hiring/Onboarding, GxP Vendor Auditing, Change Mgt, Quality Planning, Vendor Mgt, Training, Risk Mgt, Batch Record Review
PHARMA/COMMERCIAL MFG
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Expertise: QA Operations, Stability Program, GxP Training, Consent Decree, Warning Letter, 483 Remediation, Cleaning Validation, CMC, Analyst Certification Program
QC & LAB OPERATIONS
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Expertise: Good Laboratory Practices, Housekeeping, Product & In-Process Testing, Batch Record Review, Commercial GMP Manufacture, FDA Audit, CSV, Method Validation/ Verification, Analytical Method Transfer, Equipment PM/CM
My career in cell and gene therapy has given me a front-row seat to some of the most groundbreaking advances in modern medicine. At Penn’s Center for Cellular Immunotherapies, I supported the CAR-T program that ultimately became Kymriah - the first cell therapy approved in the U.S. - by embedding GMP and QA strategies into an environment where research was moving faster than the systems around it.
At Gyroscope Therapeutics, I was given a blank canvas to build the Quality organization. I developed the QMS from the ground up, redesigned vendor management and audit programs, and streamlined critical processes so they were both compliant and practical.
When Novartis acquired the company, I guided quality activities through the inevitable growing pains of integration, shifting priorities, pressing timelines, and organizational change. These experiences sharpened my skills in strategic planning, change management, and cross-functional collaboration, and reinforced my belief that Quality can empower innovation instead of slowing it down.
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In the PHARMA sector, I built a strong foundation in commercial GMP environments by supporting and improving core QA processes. On assignment for GSK, I managed a portion of their GMP training program, requiring strategic vision and international travel to deliver critical QMS topics. I developed a global training program, executed internal audit plans, and championed change management across multiple global sites.
Supporting a project at McNeil's Johnson & Johnson, I engaged in FDA 483 remediation efforts and directed large-scale change management projects. At Cordis, also with Johnson & Johnson, I served as a global expert in Cleaning Validation, ensuring compliance across multiple international sites. My problem-solving skills contributed to the development of a document archival system, which received positive feedback from senior leadership. As a Training Consultant at the San German site in Puerto Rico, I developed and delivered a scientific training program in response to an FDA 483, ensuring certification and competency among QC Lab staff. I really enjoyed teaching younger laboratory staff valuable tips of the trade that come only with experience!
The official start of my career was as a self-proclaimed lab rat (and oh, how I loved it!) — pulling graveyard shifts in Eli Lilly’s QC/GMP lab, running in-process and final product tests for small molecules. My survival strategy? Riding up and down the manufacturing floor on the lab tech “golf cart” to stay awake between samples! That killer night shift propelled me into graduate school, and when I returned to Lilly as a Project Chemist, I was given carte blanche to do what I love most: find smarter, faster, simpler ways to work. I redesigned procedures that cut down deviations, created troubleshooting guides that actually worked, and aligned testing with international standards.
One of my favorite wins was eliminating redundant chromatographic testing, an FDA-reportable change that reduced cycle time from five days to three and saved significant costs, which was then replicated multiple times across the lab for other groups and operations. I also drove countless process maps to spot and eliminate waste. Even back then, I was happiest when I was solving problems, streamlining work, and making quality systems more efficient (with or without the golf cart).
