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.
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 links to 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
Create fit-for-purpose QMS, QMS gap analysis.
From authoring/reviewing SOPs to building your QA organization, including hiring/onboarding QA staff.
Meet the Founder
"Scientist at heart, Quality Crusader on the field!"
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30 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
As I enter this new and exciting stage of my career, I would like to focus on finding projects and assignments where I'll have the opportunity to simplify GxP quality management systems. This passion of mine is driven by a commitment to eliminate redundancies, duplication of efforts, and inefficiencies. Those who have worked with me know that I like simplification, efficiency, and straightforward processes.
With over 30 years of experience in the pharma and biotech sectors, I've honed my skills in streamlining and enhancing quality processes using LEAN principles. Auditing and Vendor Management have become key aspects of my work, allowing me to identify areas for improvement and ensure compliance with regulatory standards.
My consulting practice is dedicated to helping emerging biotech companies establish quality management systems that are fit for purpose. My goal is to strip away complexities and deliver straightforward quality solutions that are easier to follow and maintain, particularly for organizations in pre-clinical or early clinical stages. My pragmatic approach ensures compliance while avoiding convoluted QMS processes that are difficult to understand and implement, let alone follow!
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
The Simple Quality Systems Difference
International Capabilities
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.