Pharmaceutical Quality Assurance Expert: Solid Oral, Injectable, and Biologics GMP

Expertise

• Pharmaceutical quality assurance management and corporate quality strategy planning.
• Development and implementation of phase-specific quality systems
• Identifying and correcting road blocks to efficiency and compliance
• GMP facility design, construction management, validation and licensing of GMP manufacturing facilities.
• Proven success in U.S. and E.U Inspections of manufacturing and laboratories.
• Over 20 years of valuable experience developing and managing highly productive work groups in small to mid-size pharmaceutical.

Experience

Undisclosed Company, Associate Director of Quality Assurance and Quality Control, 2011 - 2014

• Senior leadership of quality departments, creating, implementing, and maintaining robust quality systems designed to meet the evolving needs of pre-clinical, early and late stage product development.
• Created and managed the Quality Control Department - reviewing and approving all QC product procedures, environmental monitoring, WFI, RODI, gas systems sampling and testing, drug substance and drug product stability, and the raw material testing program.
• Managed outsourcing of testing to ensure high quality testing results.
• Review and approval of product-specific analytical and bio-analytical testing procedures and method qualification protocols, reports and data.
• Supervision of QC and environmental monitoring employees and sourced and purchased all of the quality control and environmental monitoring equipment.
• Created and managed the Quality Assurance Department: Created, implemented, and maintain of company's Biologics quality systems including document control, GMP equipment systems, calibration and validation programs, CAPA, out of specification and out of tolerance SOPs, complaint systems, and internal and external audit procedures.
• Review and approval of draft production batch records and executed batch records for Bio-Similar products.
• Directly responsible for the management of the validation of a 55,000 square foot GMP manufacturing and testing facility. Validated utilities include RODI, clean steam, CO2, O2, and CCA gas systems, HVAC, autoclaves, and WFI systems.
• Review and approval of all validation protocols and reports and data. Technical point-person for equipment validation challenges and issues.
• Proven success managing service vendors used for equipment start-up, maintenance, repair and testing of facility utilities, lab equipment, and IT network and phone systems.
• Coordinate the installation, validation, and implementation of 21 CFR Part 11 compliant temperature and humidity monitoring and alarm system for all GMP clean rooms, incubators, refrigerators, warm-rooms, and freezers.
• Review and approval of validation protocols and results and data. Technical point-person for the monitoring system.

Eastlake Quality Consulting, Chula Vista, CA, Principal Consultant, Owner, 2011 - 2013

• Auditing of global manufacturers, laboratories, and contractors for GMP compliance. Manufacturer dosage forms include solid oral, injectable, and biologics.
• Quality assurance management of the validation of aseptic biologics manufacturing facilities and licensing through the California Food and Drug Branch.
• Management and coordination of all contractors for facility validations including HVAC, WFI and USP purified water systems, autoclaves, bioreactors, clean steam generators, vial and glass washer, biological safety cabinets, electronic security systems, incubators refrigerators and freezers.
• Review and approval of all facility validation protocols, testing data, and reports.
• Authoring of procedures for manufacturing operations, quality control, quality assurance, shipping and receiving, facilities, non-conforming material investigations, CAPA, complaint systems, testing equipment, and outsourcing.

Pharmatek Laboratories, San Diego, CA, Director of Quality Assurance, 2002 - 2010

• Successfully lead-hosted a six-day FDA pre-approval inspection for two client pharmaceutical products.
• Senior management supervision of 14 European QP inspections and 40 to 60 client audits per year.
• Developed and implemented quality systems to support manufacturing, testing, and distribution of clinical products to Europe and the U.S.
• Design, construction management, validation, and licensing of two separate Class 100,000 (ISO 8) manufacturing facilities: (1) 16,000 square foot facility for handing of cytotoxic and high potent compounds, (2) 34,000 square foot facility for handling of non-cytotoxic and non-high potent compounds.
• Primary point of contact within QA to resolve technical challenges in the analytical labs and for all facility related non-conformances.
• Supervise 9 quality assurance staff members including document control and QA supervisors and managers.
• Author and negotiate Quality Agreements between clients and Pharmatek.

Manager of Quality Assurance, 2002 - 2006

• Design, construction management, validation and licensing of two Class 100,000 (ISO 8) manufacturing suites and support areas.
• Authored Pharmatek's facility and validation master plans.
• Developed and implemented Pharmatek GMP and GLP quality systems.
• Perform internal audits of Pharmatek compliance systems, conduct audits of external vendor and suppliers, and hosted client inspections.
• Review and approval of manufacturing batch records, laboratory data, reports, COAs, and laboratory and manufacturing equipment validations.
• Ensure that specification results are fully investigated and corrective actions are justified and in compliance with cGMPs.

Corvas International, San Diego, CA, Manager of Quality Assurance, 2001 - 2002

• Performed external audits for vendors and service providers.
• Quality assurance approval of clinical packaging label proofs and final labels, randomization codes, packaging configurations, packaging validations, and batch records performed by external vendors.
• Reviewed and approved all data generated by the quality control.

Magellan Laboratories, (Cabrillo Facility), San Diego, CA, Quality, 1998 - 2001

Assurance Auditor III and Training Coordinator

• Lead hosted client audits and tours, performed internal laboratory audits, and conducted QA review of laboratory notebooks, reports, and COAs.
• Audited notebooks, reports, and COAs pertaining to GLP, GMP release and stability testing, and method development and validation studies.

Amylin Pharmaceuticals, San Diego, CA, 1994 - 1998

• Filled numerous positions: Research Associate, Senior Research Assistant, and Research Assistant for the Department of Analytical Chemistry.

Honors & Publications

Academic and Professional Affiliations

• Focused studies: Neurobiology and Histochemistry

Publications

Author of peer reviewed publications and speaker, topics:

• CMO Vetting Process
• Supply Chain Management, APICS-ASQ
• Efficiencies in Stability Testing

Education

• M.A. Physiological Psychology, San Diego State University, San Diego, CA
• B.A. Physiological Psychology, San Diego State University, San Diego, CA