VP, Regulatory Affairs/Quality Assurance, Biolex
Pittsboro, NC.

• Managed the Regulatory affairs, Quality Assurance and Quality control functions for Biolex.
  
• Assure compliance with applicable federal, local and international regulations.
  
• Develop regulatory strategies for the development of biopharmaceuticals
  
• Conducted Pre-IND meetings with the FDA and EU authorities
  
• Establish and maintain quality systems.
  
• Provide QA and QC support for the establishment of a GMP clinical supply manufacturing operation
  
• Interact with CROs in conducting preclinical studies and IND preparation
  
• Represent Biolex in interactions with regulatory agencies, and industry organizations.
  
• Represent Biolex QA/QC/RA in interactions with US and international partners and in due diligence activities
  
• Successful filings of an IND and CTAs for alpha interferon Phase 1 and Phase 2 clinical trials
  

Vice President of Quality Systems, Xanthon
Research Triangle Park, NC.

• Responsible for establishing The Quality Systems for Xanthon in compliance with the Quality System Regulations and establishing the QA/QC functions.

Associate Director of Quality, Biogen
Research Triangle Park, NC.

• Responsible for the overall management of the Quality Assurance and Quality Control operations for Biogen's RTP bulk Avonex manufacturing site including QA Compliance, Documentation, QA Chemistry, QA Biology, Bioassay and Virology.
  
• Directed QA, QC and CMC activities for BLA submission and licensure of the Biogen RTP Avonex manufacturing facility
  
• Established the QA/QC functions for the start up of the manufacturing site and guided the facility to successful preapproval inspections by the FDA, EMEA, Canadian and Russian authorities achieving FDA licensure within 33 months form the initiation of construction.
  
• Responsible for review and approval of all validation protocols
  
• Primary contact for FDA and other regulatory agencies including a successful Team Biologics inspection.

Director of Quality Assurance, Pharmacia
Clayton, NC.

• Responsible for overall management of the Quality Assurance and Quality control functions for Pharmacia's US LVP and lipid based drug delivery operations including QA Inspection, Quality Engineering, QA Compliance, Documentation, QA Biology and QA Chemistry.

Quality Engineer, Pharmacia
Clayton, NC.

• Managed QA Inspection and Quality Engineering functions.
  
• Established internal audit program and supplier QA program
  
• Provided technical support for validation activities and reviewed and approved validation protocols

Quality Control and Sterilization Manager, Becton Dickinson (B-D Division)
Canaan, CT.

• Responsible for management of the Quality Control and Sterilization departments of a 600 employee Medical Device Manufacturing facility.
  
• Responsibilities included management and validation of EO, Cobalt and E-beam sterilization processes, Technical Services, Quality Improvement, QC Inspection and Microbiological testing, environmental monitoring, validation of non-sterilization processes.
  
• Primary contact for FDA and NRC inspections
  
• Participated in Juran Quality Improvement program
  
• Oversaw the successful commissioning of the E-beam sterilization operation
  

Chief Microbiologist, Becton Dickinson (B-D Respiratory Care)
Ocala, FL.

• Responsible for management of the Microbiology and Sterilization Departments including EO sterilization operations, sterility testing, environmental monitoring, validation of EO and aseptic filling operations.

Microbiology Manager, C.R. Bard, Bard Urological Division
Covington, GA

• Responsible for start-up and management of the Microbiology department and EO sterilization validation.

Quality Engineer, C.R. Bard, Bard Urological Division
Covington, GA.

• Responsible for establishing incoming inspection, in-process and finished goods inspection procedures and EO sterilization validation

Microbiologist, Becton Dickinson
Rutherford, NJ.

• Responsible for sterility testing, environmental monitoring, E-beam and EO sterilization validation

• ASQ Certified Quality Engineer and ASQ Certified Quality Auditor