Patricia Squitiero

QUALITY SYSTEMS OWNERSHIP & REGULATORY CONSULTING • Provide strategic consulting on regulatory needs & business process improvements across medical device, biotech, pharma, & life sciences organizations • Provide hands-on oversight & continuous improvement of medical device & life sciences QMS, ensuring compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR/IVDR, MDSAP, & FDA expectations • Develop, author, review, & update QMS procedures, SOPs, & work instructions governing document control, NC/CAPA, audits, calibration, training, & Management Review • Draft & implement SOPs supporting GLP, GCP, & OECD standards; develop procedures addressing site GLP/GCP needs & regulatory compliance • Manage document control, records management, & validated QMS platforms(Veeva Vault, MasterControl, IQVIA), ensuring data integrity & inspection-ready records • Develop & own training plans; oversee complete training plans, records, & controlled training files • Coordinate internal, external, & supplier audits; support Management Review inputs & periodic quality system reviews • Manage NC & CAPA reviews, including root cause analysis & Verification of Effectiveness (VoE) • Oversee calibration & metrology tracking; support calibration & periodic system audits • Design & maintain quality metrics, dashboards, KPIs, & risk-based trending • Conduct onsite facility & laboratory inspections; support FDA, EMA, USDA, & AAALAC inspections REGULATED SYSTEMS & GOVERNANCE • Lead regulated software implementations in compliance with 21 CFR Part 11, including SDLC execution & Computer Systems Validation (CSV) • Provide vendor & managed service provider oversight; track service metrics & delivery accountability • Perform raw data reviews for medical devices, biologics, & biotech programs to ensure data integrity, traceability, & inspection-ready records • Support governance of regulated digital systems, including Software as a Medical Device (SaMD), including change control & post-market monitoring

CAPA Support for Regulatory Affairs- New Product Development Team on Labeling Compliance for In Vitro Diagnostics (IVD) Medical Devices Cepheid is an American molecular diagnostics company that is a wholly owned subsidiary of Danaher Corporation. Its systems automate traditional nucleic acid tests (tests for specific sequences of DNA or RNA). The tests can be used to identify and analyze pathogens and genetic disorders. keywords: 21 CFR 809, ISO 13485, 21 CFR 820, Agile Product Life Cycle Management (PLM) systems, Corrective and Preventative Actions (CAPA)

Owned and led site-level QMS compliance across GLP, GCP, and OECD programs supporting medical device and biologics testing for U.S. and international sponsors. Served as QA Site Lead and primary regulatory liaison for FDA, USDA, EPA, and local health authorities, directing inspection readiness, audits, and regulatory responses across $10M+ in sponsor portfolios. Managed enterprise quality processes including deviations, nonconformances, CAPA, Verification of Effectiveness, training compliance, document and records management, and data integrity, maintaining validated, inspection-ready systems aligned with global regulatory standards. Led raw data reviews, phase audits, supplier qualification, calibration and metrology compliance, and continuous improvement initiatives, while developing quality dashboards, KPIs, risk assessments, and annual quality plans for senior leadership. Supervised and mentored QA teams of up to 12–15 staff, driving cross-functional audit readiness and sustained compliance across global programs, leveraging Veeva Vault as the primary QMS.

a leading American biopharmaceutical specializing in discovering, developing, and commercializing innovative therapeutics for life-threatening diseases. Focused on virology, oncology, and inflammation.

Appointed Voting Member in a Non-lawyer, Consumer of Legal Services Role The working group is charged with addressing the following: Exploring the development of a regulatory sandbox. Considering amendments to rule 5.4 regarding fee sharing. Issuing for public comment a new rule 5.7 addressing the delivery of nonlegal services provided by lawyers and businesses owned or affiliated with lawyers. Considering recommendations for amendments to the Certified Lawyer Referral Service statutes and Rules of the State Bar. Disclaimer: LinkedIn Posts and Presentations made by me, represent my views and not the views of the working group.

Ambys was a biotechnology company cell therapy platform to create, scale, and transplant healthy liver cells. Their strategies include cell, gene, and drug therapies to tackle diseases that are currently undertreated. Key words: Preclinical QC/QA, FDA & AAALAC Compliance, GLP Nonclinical Studies, Pre-IND Regulatory Readiness, CRO Oversight & Audits, Vivarium & Animal Research Compliance, Biosurveillance Programs, Inspection & Audit Readiness, SOP & Quality Systems Development, QMS, Environmental Monitoring & Bioburden

Keywords: Python, GitHub, Terminal, Pandas, Anaconda Programming & Data Prep for AI Machine Learning Fundamentals & AI Ethics Natural Language Processing & AI Applications cutting-edge AI topics such as neural networks, deep learning, natural language processing, transformers, and emerging topics in AI. AI Bootcamp