Pathway is accelerating breakthrough solutions for the betterment of patients around the world. Key Roles:1. Lead the Pathway Chief Quality Officer Team, whose mission is: Mobilizing Enterprisewide Effectiveness. This team is a Team-in-Action that sponsors initiatives that will help achieve quality breakthrough outcomes across the industry. Examples include: - The Quality Science Education Program (100% free for students and universities!): to prepare the next generation to join our industry, armed with critical thinking skills and an understanding of why we do what we do. - The QMS Agility Initiative: to develop a tool that industry can use to pivot "how" their Quality Management System is implemented under various critical pressures. - The Quality Maturity Model: to integrate many maturity models, anchor each stage to a business outcome, and advance the role of Quality into the digital age. - Several other initiative topics: Annex I, metrics that matter, emotional intelligence, eBRs with smart capabilities.2. Created and lead the Quality Science Education Program, which provides industry-developed college level courses for students and universities all over the world. 1,000+ students from 200+ universities on 5 continents have gone through the program.3. Created and Lead the Quality Operations Forum, to provide 60+ live meetings on critical topics needed to effectively support patient success through proactive and predictive quality practices. Members span the globe!

Founded and led the development of Xavier Health, which established partnerships with FDA and global regulators, as well as industry experts around the world. Led initiatives such as the FDA/Xavier Pharmaceutical Metrics Initiative, the development of the Good Supply Practices (which became the foundation for the USP Chapter on Supplier Quality), and the Xavier Cultural Initiative (which has been used by regulators on inspection). I am grateful to have had the opportunity to engage with so many passionate industry members and regulators in the pharmaceutical, medical device, combination products and artificial intelligence spaces. You inspire me every day!Key Roles:- Established partnerships with global regulators to work collaboratively with industry.- Founder and Chair of the FDA/Xavier Medical Device Conference (MedCon) 2010 - 2021- Founder and Chair of the FDA/Xavier Pharmaceutical Conference (PharmaLink) 2010 - 2021- Founder and Chair of the Xavier Combination Products Summit 2014 - 2021- Founder and Chair of the Xavier AI Summit, Working Teams and Expert Network 2017 - 2021Key Outcomes:- Co-led with FDA the FDA/Xavier Medical Device Metrics Initiative, which formed the basis for CDRH's Case for Quality.- Co-led with PwC the Xavier/PwC Pharmaceutical Metrics Initiatve toprovide industry with insight on how to proactively measure outcomes from R&D through commercialization to reduce risk of product and process failures.- Co-led with industry and FDA the Good Supply Practices (GSPs) in response to the heparin tragedy. Main takeaway - industry has a major role in creating the supply chain challenges it is facing. How qualified are you to be in your own supply chain?- Created a partnership with Amerisouce Bergen to conduct an end-to-end serialization pilot in response to serialization requirements.- Created and led numerous Learning and Development opportunities for pharma, device, combination products and AI communities.

* Conduct mock Pre-Approval Inspections for Pharmaceutical Clients all over the world. These inspections enable clients to better understand their compliance level in light of FDA expectations.* Conduct contractor audits for Pharmaceutical Clients. These system-based audits provided critical information to client companies about the compliance status of their contractors. * Provide technical support for manufacturing, packaging, and laboratory validation studies. Ensure that study design is appropriate, data is understood, and conclusions are scientifically justified.* Serve as an expert witness to the pharmaceutical industry.

Had the opportunity to leave the workforce fulltime to raise our children. I continued staying at home while founding and launching Xavier Health, then moved back into the workforce fulltime as our children started into school. I am so grateful to have had this time with them!

As I transitioned into becoming a stay-at-home mom, I moved into a newly created role at Merck to develop supplier agreements between Merck and 3 party partners, which became the template and process used by Merck for contractors and vendors. Absolutely loved everything I did with Merck, and am grateful for the opportunities I had to learn, lead and support this great organization.

The NC facility Quality Operations position included oversight of the North American Stability Hub for Merck, Manufacturing Operations, Packaging Operations (internal and contracted), Laboratory Management, and Vendor Management. Represented the site during FDA inspections.

Led multiple teams of chemists for new product launches, technical studies, validations and all aspects of non-sterile product testing. Led task forces that established global Merck best practices, and represented the laboratory during FDA inspections.

Led laboratory teams of chemists to support the testing of the West Point plant site products, including over 20 products of varying formulations and 5 successful new product launches.

Supported new product launches through analytical method development, validation, transfer and technical support to global Quality Control sites.