Senior Consultant, Biologics Consulting Group, Inc., Antioch, CA

Global Head of GMP Compliance/ Senior Director Regulatory Compliance, Novartis/ Chiron Corporation.

• Designed and developed a global/corporate regulatory compliance department that ensured compliance with GMP and ISO regulations at six manufacturing sites in four different countries.
  
• Met all applicable regulatory requirements in construction of new sites/facilities as well as modifications to registered sites, processes, and equipment.
  
• Hosted FDA, global and international regulatory inspections.
  
• Influenced the development of sustainable corrective and preventive actions that minimized overall compliance risk and resulted in the re-license of a suspended product/process
  
• Worked closely with in-house counsel to develop commitment responses that met legal and technical requirements of regulatory agencies
  
• Designed and performed mock Pre-Approval Inspections, (PAI's) that resulted in successful product launches or acceptance of new or extensively modified facilities
  
• Headed team performing GMP, GCP and ISO internal audits that met all regulatory requirements
  
• Led the development of business requirements for global e-solutions (using TrackWise) that automated:
  
  • The accumulation and evaluation of inspection and audit information and findings
    
  • Discrepancy investigations and reports
    
  • Pharmaceutical technical complaints
    
  • Tracking and trending techniques that led to sustainable Corrective and Preventive actions (CAPA)
    
• Appointed as the sole Chiron executive on the Executive Steering Committee overseeing the integration of Chiron programs into Novartis Vaccines and Diagnostics systems
  
• Approved the development of and implementation plans and metrics for a global quality manual consisting of approximately 100 quality modules including those governing quality and technical agreements with CMO's and CTL's.
  
• Provided final compliance review and approval of GMP documents to support regulatory submissions
  
• Led introduction of Kepner-Tregoe system as discrepancy and complaint investigation tool which resulted in the implementation of the process at manufacturing facilities

Senior Director, Global Compliance Operations, Wyeth Pharmaceuticals

• Responsible for global compliance program and corporate quality services for four business groups involved in the production and control of clinical trial materials (CTM's).
  
  • Groups developed and manufactured vaccines, biopharmaceuticals, traditional pharmaceuticals (small molecules) and over the counter (OTC) products.
    
• Ensured remediation efforts were in line with responses to Consent Decree commitments
  
• Provided first line communication and problem solving with Consent Decree third party verifiers
  
• Approved Part 11 compliance program for key manufacturing and laboratory functions
  
• Approved GMP training materials and courses for multiple disciplines at multiple sites
  
• Oversaw the development of and approved cGMP standards for First In-Man to Phase IV products
  
• Established CTM related metrics for integrated management reporting
  
• Developed technology transfer standards that minimized start-up problems with 3rd party manufacturing and testing CTM's
  
• Developed appropriate links between GMP policies and GLP policies for CTM's
  

• Served as the North America representative for the integration and implementation of complete quality program for newly formed Syngenta which included the development of a sustainable program covering quality operations in the United States, England, Belgium, Brazil, Switzerland, Guatemala, Puerto Rico, Japan and Canada which resulted in a strong, efficient and effective program that addressed all elements of quality. Left Syngenta because corporate offices relocated to another locale/state.

Manager, Quality Assurance, AstraZeneca/Zeneca/ICI

• This global position was initiated under ICI and transitioned into Zeneca and then into AstraZeneca after the merger of Astra and Zeneca.
  
• Responsible for quality programs at USA sites as well as those programs governing materials manufactured and shipped to the United States from the United Kingdom, Belgium, Japan, and South America.
  
• Directed and managed global quality and compliance programs for the division manufacturing active pharmaceutical ingredients, API, and technical grade and formulated agriculture products.
  
• Established three tier GMP quality manual that was the foundation for site manuals
  
• Directed crisis management program relative to product integrity issues
  
• Systematized process for determining the need for stop sales or recall of products
  
• Developed and implemented global vendor qualification program that ensured consistent product integrity across multiple sites in multiple countries
  
• Approved final product specifications, quality control test methods and multi-site operating procedures
  
• Developed holistic product evaluation process that discovered and corrected minor manufacturing adjustments and prevented the distribution of adulterated product
  
• Designed and chaired IUPAC/ICH discussion panel on global harmonization of analytical methodology
  
• Served as division's quality representative on major regulatory issues
  

Supervisor, Analytical Research & Development Laboratory, AstraZeneca/Zeneca/ICI

• Co-developed and executed GLP program
  
• Performed mock GLP inspections that led to successful official GLP inspections
  
• Developed in-house reporting format for GLP studies and initial GLP archives
  
• Developed and managed reference standard program, including purification and distribution of standards for active ingredients, impurities and metabolites
  
• Managed characterization studies of toxicology materials used to support product registration of active ingredients and physical studies of formulated products
  
• Worked directly with internal regulatory officers and governmental regulatory bodies
  

• Ford Foundation Fellow (Janice W. Reed)
• National Merit/National Achievement Scholar
  
• National Science Foundation Trainee

PROFESSIONAL SOCIETIES

• American Society for Quality (AQS)
  
• American Chemical Society (ACS)
  
• Parental Drug Association (PDA)
  
• Regulatory Affairs Professionals Society (RAPS)
  
• Society of Quality Assurance (SQA)
  

CONTINUING EDUCATION

• Executive Leadership
  
• Sarbanes-Oxley
  
• Change Management
  
• Total Quality Management
  
• Management Systems Auditing
  
• Supplier Performance Improvement and Certification
  
• Clean-Down Validation for Pharmaceutical Processes
  
• Quality Assurance for Pharmaceuticals and Medical Devices
  
• ISO 9000 Program and Auditor Training
  
• MRP II
  
• cGMP
  
• CBER and CDER Guidelines
  
• WHO Regulations
  
• EMEA Annexes and Guidelines
  
• CFR 21 Part 11
  
• Business Ethics