INTRODUCTION
Quality and compliance champion with extensive regulatory experience assessing, remediating and fostering quality and compliance for a variety of domestic and international FDA regulated establishments. Expertise includes identifying nonconformance within and across processes, determining root causes, developing and deploying viable solutions.
KEY ACCOMPLISHMENTS
- Managed consent decree commitments at American Red Cross Biomedical Headquarters and coordinated FDA 483 inspection responses for Red Cross blood collecting and testing facilities
- Created a series of On-the-Job training modules for the Quality Assurance function of a Biotechnology manufacturing facility after conducting an “as is” assessment of relevant SOPs and practices
- Developed an internal audit process for plasma fractionator facilities to assess the plasma collection centers prior to the FDA pre-license inspection that led to successful FDA compliance inspections at all facilities.
- Supervised the Information Management Quality Assurance section and performed final quality reviews for medical device software developed under 510K requirements
WORK EXPERIENCE
Pharmaceutical Consultant 2011 - Present
Acton, MA
- Perform quality assessment of pharmaceutical operations and review facilities and documentation for compliance to regulatory requirements.
- Institute compliant quality systems and mentor personnel in quality assurance, quality control, and manufacturing to assure compliant drug development and production.
Independent Consultant 2005-Present
DMJ & Assoc., Inc., Columbia, MD
Provide quality management, policy and procedure development, training, regulatory audit and compliance services to Biotechnology and Medical Device facilities, Clinical Laboratories, and accreditation organizations.
- Performed baseline audit for Quality Operations at Biotechnology facility and developed remediation plan including training for compliance deficiencies.
- Developed a record review process for a biomedical facility with a market withdrawal/retrieval backlog of twenty thousand records to eliminate the backlog and ensure compliance.
- Conducted in-depth assessments at five plasma fractionator facilities with a team of auditors that consisted of a gap analysis of compliance profiles, 100% record review of six months of data, observation of all phases of production, and development of corrective and preventive actions, and all facilities completed the subsequent FDA assessments with none or only minor observations.
Various Positions Culminating in Director 1997 - 2005
American Red Cross, Biomedical Headquarters
- Managed all aspects of the Red Cross commitments to the FDA under the Consent Decree of 1993.
- Tracked all commitments and managed interim and final documentation for completion of corrective and preventive actions, and published the quarterly and annual reports submitted to the FDA in response to Consent Decree requirements.
- Reviewed and edited FDA 483 inspection responses for 38 Red Cross blood collecting and 10 testing facilities to ensure that the investigations and root cause analysis clearly addressed the inspection observations and the corrective and preventive actions (CAPA) were complete and met internal timelines.
- Established and implemented a Senior Level Quarterly Quality Monitoring Committee that provided management with a comprehensive and efficient process to systematically monitor and evaluate multiple quality indicators and to identify areas for targeted corrective and preventive actions.
AWARDS
- Selected for the College of American Pathology Forensic Toxicology Drug Testing Inspection Team that inspected the forensic drug-testing laboratory for the Summer Olympic Games held in Atlanta.
EDUCATION
- Biochemical Regulatory Engineering Program Concentration Track, University of Maryland, Baltimore County (UMBC), Certificate, 18 CEUs
- Master of Science [Laboratory Medicine], University of Washington, Seattle, WA
- Bachelor of Science [Biology], Marymount College, Tarrytown, NY
CERTIFICATIONS
- American Society for Quality (ASQ)
Certified Manager of Quality/Organizational Excellence
Certified Quality Auditor (CQA)
- American Society of Clinical Pathology (ASCP)
Certified Medical Technologist
- American Association for Laboratory Accreditation (A2LA)
Certified Auditor, ISO 15189, “Medical laboratories – Particular requirements for quality and competence”
Certified Auditor, ANS/ISO/IEC 17025, “General Requirements for the competence of testing and calibration laboratories”
PROFESSIONAL AFFILIATIONS
- American Society of Clinical Pathology (ASCP)
- American Association of Clinical Chemists (AACC)
- Clinical Laboratory Manager’s Association (CLMA)
- Clinical and Laboratory Standards Institute (CLSI)
- Medical Technical Committee (A2LA)
- Criteria Council (A2LA)