Brandy Lewis's Email Addresses & Phone Numbers

📖 Summary

Senior Director, GMP Compliance @ La Jolla Pharmaceutical Company • Managed the company’s GMP Quality System to support development and commercial activities.• Managed all aspects of GMP Quality to support development and commercial products.• Led inspection readiness efforts.• Provided GMP Vendor oversight. From August 2018 to January 2020 (1 year 6 months) San Deigo, CAPrincipal Consultant @ Independent Consultant • GMP focused Quality Consultant• Batch record reviews (Drug Substance, Drug Product, analytical data, and clinical trial material), Quality Event reviews (deviations, investigations, etc.), write phase appropriate SOPs to support or build a Quality Management System, and perform Vendor audits. From October 2015 to August 2018 (2 years 11 months) Head/Senior Director of Quality Assurance @ Apricus Biosciences, Inc. Developed and implemented Quality Management System for development and commercial phase products virtually manufactured and tested.Responsible for all aspects of Quality.Co-Managed Contract Service Providers.Reviewed EU variations and US NDA dossier. From October 2015 to December 2016 (1 year 3 months) Greater San Diego AreaPrincipal Quality Consultant and Director, Quality Consulting @ Thirteen Consulting Group, Inc. Business development and managed West coast Quality consulting to companies in the biotech, pharmaceutical, and medical device industries.Client services included, but not limited to: prepared and led inspections, delivered group trainings, wrote Quality Agreements, reviewed API and Drug Product batch records and analytical data, reviewed deviations and investigations, wrote SOPs, developed Quality programs, performed gap analysis, and audited Vendors, etc. From September 2014 to October 2015 (1 year 2 months) Massachusetts and CaliforniaDirector of Quality Systems/Head of Quality @ Evofem and Cosmederm Biosciences Develop and responsible for Quality Management System for devices, drug, OTC, and cosmetics.Management Representative.Manage group of 3 professionals and oversee their development and promotion to more senior roles. From September 2013 to July 2014 (11 months) Associate Director of Quality Systems @ Shire Regenerative Medicine Developed, led, and optimized Quality Systems supporting life cycle of combination biologic/device in clinical and commercial setting.Led FDA, FDB, ISO, AATB, and other Health Authority inspectors during cGMP inspections.Developed and implemented Quality Event (e.g., deviation, nonconforming material, corrective/preventive actions) electronic system. From March 2013 to September 2013 (7 months) Quality Systems Manager @ Shire Regenerative Medicine (formerly Advanced BioHealing) Provided Quality System oversight of commercial and clinical manufacturing of product on site.Supported regulatory filings with technical content and submission review. From November 2010 to March 2013 (2 years 5 months) Quality Systems Manager @ Life Technologies Provided Quality oversight of Quality Systems.Established Visual Controls in Manufacturing/Operation teams, Quality Metrics, Quality Scorecard, and Strategy Deployment Matrix for monitoring and reporting for the site.Developed site road map and Quality Manual, resulting in successful recertification for ISO 9001:2008 for Site Distribution Center. From March 2009 to November 2010 (1 year 9 months) Associate Director of Quality Assurance and Compliance/Head of Quality @ Kalypsys Developed and led Quality for multiple clinical stage small molecule products (start-up to Phase IIb) supporting life cycle of drug product.Performed oversight of contract firm management (nonclinical, clinical, and cGMP manufacturing). From July 2007 to March 2009 (1 year 9 months) Associate Director of Quality Assurance and Compliance @ Anadys Pharmaceuticals Developed and led Quality for multiple small molecule clinical stage products (start-up to Phase IIa) supporting life cycle of drug product.Performed oversight of contract firm management (nonclinical, clinical, and cGMP manufacturing).Supported regulatory filings with technical content and submission review.Implemented EDMS for change management. From January 2005 to July 2007 (2 years 7 months) Sr. Manager of Quality Assurance @ Favrille Developed and led Quality for multiple biologic clinical stage products (start-up to Phase III) supporting life cycle of drug product.Head of back room for FDB inspection. From August 2002 to December 2004 (2 years 5 months) Manager of Quality Assurance and Compliance @ Agouron Pharmaceuticals Led change management, training, and calibration/preventive maintenance for clinical and commercial products.Member of successful PAI. From July 1996 to August 2001 (5 years 2 months) Senior Manager, Quality Assurance and Compliance @ Pfizer Led change management, training, and calibration/preventive maintenance for clinical and commercial products.Member of successful PAI. From 2000 to 2001 (1 year) Quality Control Sr. Research Associate @ DepoTech Technical development across lab functions (research & development, toxicology, analytical methods development) to senior technical role in Quality Control From July 1992 to August 1996 (4 years 2 months) Vice President Quality Assurance @ La Jolla Pharmaceutical Company • Manages the Quality System to the standards expected by US and EU regulatory authorities to support development and commercial activities.• Ensures on-going monitoring of the Quality System.• Manages the Quality Operations and Quality Systems personnel, activities, budget, and GxP functions.• Leads the Quality Unit responsible for current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), Good Laboratory Practices (GLP), and Computer Software Validation (CSV).• Works with La Jolla management and executive management to identify deficiencies and areas for improvement.• Provides oversight for GMP, GLP, GVP, and GCP regulatory agency inspections.• Leads Inspection Readiness efforts for La Jolla.• Acts as lead/Host contact for GxP site inspections.• Provides on-going oversight of our GxP Vendors.• Provides guidance and leadership for meeting US and EU regulations.• Promotes and enforces expectations for compliance. San Diego, CASenior Director of Quality Assurance @ Regulus Therapeutics Head/Senior Director of Quality Assurance • GxP Quality Leader and Core Team Quality Representative.• Responsible for all aspects of GxP Quality and provided Quality oversight.• Evaluated existing Quality Management System and addressed documentation gaps and mitigated risk. • Developed and implemented a new GxP Quality Management System expanded from a single-compound focus to encompass multiple product development programs and mature systems.• Reviewed and approved nonclinical protocols, amendments, and reports (non-GLP and GLP).• Addressed and resolved clinical quality related issued that affected clinical trial conduct.• Developed new IND stability tracking and reporting system to ensure timely data review and compliance with Regulatory reporting requirements.• Reviewed US INDs, multi-module information amendments, and IND Annual Reports. • Instituted Corporate awareness of Quality function and improved communication across R&D business unit.• Reconfigured Quality SharePoint site for GxP documentation.• Supported due diligence activities.• Managed a team of two Quality professionals. From January 2017 to July 2018 (1 year 7 months) San Diego, CA