Passionate about sustainable Quality. Focused on current regulations. Bound to client requirements and satisfaction. Provide expertise services in the areas of Auditing, CAPA, Chemistry Laboratories, Compliance Master Plans, Data Integrity, Document Control, Inspection Readiness, Management Review, Part 11, Process Mapping, Process Validation, Project Management, Risk Analysis, Software Validation, Stability, Materials and Training.

Building a Digital and AI-led Quality and Productivity narrative for Life Sciences, Biotech and Food and Beverages companies.

CDER/Office of Pharmaceutical Quality, Division SupervisorCDER/Office of Compliance, Branch ChiefFDA Emergency Operations Center - Deputy DirectorORA Philadelphia District Office - Pharmaceutical Chemistry SupervisorORA San Juan District Office - Drug Chemistry SpecialistORA Northeast Regional Laboratory - Drug Chemistry SpecialistProvided leadership, counseling, and managerial direction to FDA management, committees and teams to accomplish surveillance activities for human drugs and biotech programs. Led specialized staff assessing manufacturing facility state of quality for human drugs and biotech programs. Provided facility and product quality intel to FDA field force in preparation for establishment inspections. Managed CDER's Certificates of Pharmaceutical Product, Declaration of Conformance, Pre-operational Facility Review, and pre-approval manufacturing facility review programs. Co-led centralized agency assistance, preparedness and response to emergencies, incidents and crisis events. Led specialized laboratory staff reviewing work products for accuracy, completeness and compliance with established human drug laws, regulations and agency policies. Performed specialized drug chemistry testing; provided technical expertise in domestic / international drug inspections.

Rhône-Poulenc Rorer/ Manatí, PR [tablets, capsules]Sterling Drugs/ Barceloneta, PR [APIs]Bristol-Myers Laboratories/ Mayagüez, PR [parenterals, lyophilized]Performed laboratory testing of raw materials, APIs, packaging components, solid dosage and parenteral drug products, and raw materials. Reviewed and approved in-process batch records and coordinated API stability program.