Boutique quality GxP consulting practice in Philadelphia​
Focusing on helping emerging GxP biotech companies at early stages of their clinical journey with a particular emphasis on auditing and managing GxP vendors.
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Primary Service Offerings​
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GxP Vendor Audits
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Vendor Mgt & Oversight
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QMS Support
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Head of QA Fractional Consulting
Straightforward. Efficient. Simple.
"We are Cellicon Valley"
Philadelphia Magazine
Philadelphia, now known as "Cellicon Valley," has become a hub for science innovation in cell and gene therapy. The main goal at Simple Quality Systems is to support small to medium-sized emerging biotech and startups entering the clinical space by providing essential GxP quality support and representation.
All services are available domestically and internationally. ​​​​
Service Offerings
Click on each item for additional information.
GxP Vendor Audits
Set-up, mgt and execution of part or all of your audit program. Offering several audit packages for a cost-effective solution for newer organizations.
Vendor Mgt/Oversight
Able to build (or improve!) your vendor management program, including qualification, onboarding, vendor oversight, and of course, auditing.
QMS Support
Fit-for-purpose QMS, Gap Assessment/Remediation.
From authoring/reviewing SOPs to building the QA organization (including hiring/onboarding QA staff).
Meet the Founder
"Scientist at heart, Quality Crusader on the field!"
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20 years of GxP experience
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MS Organic Chemistry
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Most recent assignments:
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Novartis: Head of QA Processes & Excellence
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Gyroscope Therapeutics: Head of QA Operations
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UPenn CCI: Director of GMP QA
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Previous related assignments at Eli Lilly, GSK and J&J
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I’ve spent 20 years in pharma and biotech building and strengthening quality systems, from R&D labs to commercial manufacturing, and I’ve learned one simple truth: quality doesn’t have to be boring or overcomplicated. My passion is cutting through the noise, eliminating redundancies, and designing systems people can actually use. Compliance works best when it’s clear, practical, and sustainable.
What sets me apart is my approach. I don’t just “do compliance”, I make it work for the business. Whether it’s streamlining a QMS, overhauling training, or spotting vendor gaps before they become disasters, I bring energy, clarity, and a results-driven mindset that gets teams moving forward. Quality should empower innovation, not slow it down, and that’s exactly how I lead.
Simple Quality Systems was created out of this philosophy: to help emerging biotech companies build frameworks that are fit-for-purpose, not overbuilt. Whether in consulting or in-house leadership, my goal is always the same, to deliver pragmatic solutions that foster compliance, efficiency, and trust.
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Get to know me: "I believe that having fun while working is imperative! Building great work relationships not only makes the work environment enjoyable but also fosters collaboration. By creating a positive and engaging atmosphere, we can achieve our goals more effectively and enjoy the journey together. This approach has consistently led to successful projects and long-lasting professional friendships, which are invaluable for future collaborations and continued growth." - sa​
Also offering Head of QA Fractional Consulting
Fractional consulting enables me to serve as Head of QA or similar level, on a part-time or project basis, rather than as a full-time employee. As your Head of QA Fractional Consultant, I would take a hands-on, senior leadership role within your company, providing strategic planning and execution of the quality assurance and QMS processes on a part-time basis.
This approach allows organizations to access high-level expertise and support without the commitment and cost of a full-time hire. It is particularly beneficial for small to medium-sized enterprises, startups, and companies with fluctuating project demands.
The use of fractional consultants in the biopharma sector has grown significantly, with more than 110,000 individuals identifying as fractional leaders in early 2024, compared to just 2,000 in 2022*.​​
DID YOU KNOW?
Explore in more detail some of the tasks I can personally do to alleviate your teams' workload
I am equipped to support your daily quality operations or to oversee and develop your comprehensive quality organization.
Schedule a Free Consultation
30 min
Free
The Simple Quality Systems Difference
While centrally located in Center City Philadelphia in close proximity to numerous biotech organizations, services are available across all states in the US and as well as internationally. My global capabilities include offering all services fully in Spanish. With previous experience supporting LATAM and other Spanish-speaking locations, I can effectively fully assist Spanish-speaking clients and vendors, whether it's conducting audits, or providing any of my other service offerings.
