Senior Quality Control and Compliance Consultant

Highly accomplished professional with over 35 years in research, analytical development, and quality control within regulated environments across biopharmaceuticals, vaccines, in vitro diagnostics, and medical devices. Expertise in quality management, regulatory compliance (FDA, ISO), laboratory management, and data integrity. Known for building and restructuring Quality Control (QC) departments, driving compliance across global sites, and successfully managing regulatory inspections with a track record of over 50 audits. Strong background in creating and validating laboratory management systems, developing policies, and implementing corrective actions.

Key Areas of Expertise

  • Quality Control and Laboratory Management
  • FDA and ISO Compliance (21 CFR 211, 610, 820, 809)
  • CAPA and Nonconformance Management
  • Method Validation and Technology Transfer
  • Lean Six Sigma and Cost-Reduction Initiatives
  • Laboratory Information Management Systems (LIMS) Implementation

Professional Experience

Independent Consultant
Various Locations | March 2016-Present

  • Partnered with firms such as PharmEng Technology, Pacific BioDevelopment, Black Diamond Networks, The FDA Group, Compliance Architects, and Bulletproof Documentation, providing expertise in quality control, regulatory compliance, and laboratory systems.
  • Conducted gap analyses, developed and implemented SOPs, managed CAPA projects, and provided support for regulatory audits and compliance reviews.

Senior Director, Enterprise Quality Control Systems – Hologic / Gen-Probe
San Diego, CA | June 2006-May 2013

  • Led global QC system alignment, standardizing practices across international sites, including lab practices, specification setting, and training documentation.
  • Managed LIMS implementation, from system user requirements to validation, significantly enhancing data integrity and process efficiency.
  • Provided support for QA functions in audits, material review boards, regulatory inspections, and supplier qualifications, coordinating with teams to ensure compliance with ISO 13485 and CFR 820.

Director of Quality Control & Animal Resources – Emergent BioSolutions / BioPort
Lansing, MI | Nov 2004-Jun 2006

  • Managed QC functions for Microbiology, Environmental Monitoring, and Raw Materials Testing, and maintained oversight of the animal testing facility for vaccine quality control.
  • Acted as primary QC representative for regulatory audits, providing expertise in method transfer, equipment validation, and LIMS implementation.
  • Chaired the Specifications Committee and served as the primary liaison with CBER for product testing, stability programs, and compliance submissions.

Associate Director, Compliance, Release & Logistics – Chiron / Cetus
Emeryville, CA | Mar 1987-Mar 2004

  • Directed Compliance and Release functions within QC, ensuring compliance with global standards (FDA, ICH, EU) across biopharmaceutical product lines.
  • Led the design and implementation of LIMS and eDMS, and chaired the Specifications Committee to oversee product release specifications and trending.
  • Played a key role in regulatory inspections and responses, co-authoring Corporate OOS policies and leading efforts to create company-wide compliance protocols.

Research and Analytical Development Roles – Various Organizations
Including Lawrence Berkeley Laboratory, Texas A&M University, and USDA | 1979-1987

  • Conducted NIH-funded research in animal studies for erythropoietin, and performed pharmacokinetic immunoassays and analytical method development for diagnostics.
  • Supported EPA pollution research and USDA projects, applying chromatographic and immunoassay techniques for environmental and biological analysis.

Education
Master of Science in Biochemistry
Texas A&M University, College Station, TX (Phi Sigma Member)

Bachelor of Science in Biology
University of Maryland, College Park, MD

Certifications and Training

  • Lean Six Sigma Trained
  • Certified Full Instructor (Biology) – California Community College System

Professional Affiliations

  • Parenteral Drug Association (PDA) (Member of Annual Meeting Program Committee, Moderator for Process Analytical Technology sessions)
  • Society for Laboratory Automation and Screening
  • San Diego Regulatory Affairs Network

Accomplishments and Recognitions

  • Established and validated multiple QC laboratories, implementing LIMS and eDMS solutions across global sites.
  • Successfully managed over 50 regulatory inspections with few findings and effective resolution of FDA 483 responses.
  • Reduced costs and improved process efficiencies by implementing Lean Six Sigma methodologies without compromising product quality.

Skills

  • Proficient in laboratory management systems (LIMS, eDMS), gap analysis, risk management, and CAPA.
  • Extensive technical knowledge in method validation, OOS evaluation, equipment IQ/OQ/PQ, and regulatory compliance.

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