About Me.
My consulting practice is built on over 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
Explore key points and chronology of building competencies and gaining the expertise that positions me solidly to launch this consulting practice. ​​​​​​
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CELL AND GENE THERAPY​​
(Recent Roles)
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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
I have a decade of experience in building and managing quality operations for cell and gene therapy. Starting at the University of Pennsylvania, I supported breakthrough technologies developed at the Center for Cellular Immunotherapies, spearheading GMP and QA strategies, and driving continuous improvement initiatives. I played a role in the technology transfer, leading to the licensing of the CAR-T technology to Novartis for the subsequent commercialization of Kymriah.
At Gyroscope Therapeutics, I was hired to build the quality organization, where I led the development and maintenance of Gyroscope's QMS, including the GxP Vendor Management and Audit programs, as well as all other critical quality processes. I revitalized the vendor requalification program, ensuring the vendor audit frequency was updated based on risk.
After the company was acquired by Novartis, I supported quality activities while navigating pressing timelines, shifting priorities, and organizational changes. Appointed by senior leadership, I participated in the Novartis LEAP (Learning, Empowerment, and Professional Development) program, aimed at supporting leaders in their professional growth and development. In addition, I took part in a global training program (the Novartis Value Chain Academy (VCA) program), in collaboration with the Ghana College of Pharmacists, where I helped certify pharmacists and health care professionals on QMS implementation and supply chain quality management, as part of their continued education. These experiences reinforced my competencies in strategic planning, change management, and cross-functional collaboration.
PHARMA/COMMERCIAL MFG
(Middle of my career)
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Expertise: QA Operations, Stability Program, GxP Training, Consent Decree, Warning Letter, 483 Remediation, Cleaning Validation, CMC, Analyst Certification Program
The PHARMA decade focused on supporting specific 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 US and LATAM sites. As the Latin America Lead, I spearheaded QMS remediation activities, significantly reducing CAPA backlog and increasing team engagement. I found it fascinating to adjust business practices according to the region I was visiting.
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!
QC & LAB OPERATIONS
(Start of my career)
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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
The official start of my career was as a lab rat, working late nights at the Eli Lilly QC Lab, responsible for in-process analytical testing. While I enjoyed riding up and down the manufacturing facility on our "lab tech golf cart" to stay awake between samples (don't even remind me), this killer graveyard shift propelled me to graduate school.
Upon returning to the Lilly Labs, I pushed my career to the next level and focused finding ways to simplify work processes. I was given the role of Project Chemist and granted carte blanche to propose innovative solutions to address process bottleneck and improve efficiencies. I was in heaven!
​For example, I developed procedures that significantly reduced deviations, created effective troubleshooting guides, and aligned testing procedures with international standards. For cost-savings, ​I drove an FDA reportable change to eliminated redundant chromatographic testing, resulting a cycle time reduction from 5 to 3 days, as well as numerous process mappings to identify and eliminate waste.
