2008 – present Drug Quality Assurance, LLC. PRINCIPAL CONSULTANT Quality & regulatory compliance support for all stages of clinical development & commercial manufacture. • Set up Quality Systems, standard operating procedures, Quality Agreements, support technology transfer • QA and regulatory compliance for small molecule cancer therapeutics, biotechnology cell culture and microbial fermentation, biologics, vaccines and parenteral, transdermal, oral, topical drug products • Develop, review Master Batch Records, Test Method Validation, Process Validation Protocols, Reports. • Create procedures for Batch Record review, product release, disposition and perform review and release. • Perform GMP, GLP, GCP internal audits and external audits, write reports, evaluate responses. Audit small molecule and biologics API manufacturers, drug product manufacturers of all types - oral dosage forms, inhaled, aseptic fill and finish, devices; contract testing labs, excipient, packaging suppliers • Create external and internal audit programs and schedules, train personnel in performing audits. • Supplier risk assessment, Supplier Qualification for drug, device, components, distribution, testing labs. • QA, regulatory compliance for devices. Advise clients on 2011 changes in medical device regulations. 2006 – 2008 Wyeth Biotech, Biotech External Supply, Wilmington, MA. QUALITY ASSURANCE DIRECTOR. Directed the External Supply Quality group – responsible for quality oversight of cell culture and small molecule drug substances (API’s), vaccines made by contractors, and aseptic fill and finish drug product. • Managed quality oversight of multiple contractors, collaborated with contractors to improve compliance. • Prepared for and hosted FDA and other Agency Inspections, wrote responses to observations. • Implemented Management Controls, led Management Review meetings, global regulatory compliance. • Identified, remediated Quality Systems issues, performed Risk Management. • Consent Decree remediation. Evaluated Internal & External Audit results. Improved Quality Agreements. • Streamlined Batch Record review and Product Release and Disposition procedures. • Mentored QA Managers to enhance control of contractor quality performance. • Led and resolved complex investigations, improved Corrective & Preventive Action (CAPA) management. • Developed Contractor Risk assessment tools, Bioburden Risk Assessment procedures.