Global Quality Leader

In over 20 years of consulting, I have assisted a number of early development-stage pharmaceutical companies develop a QMS that fits their current stage of development. I have performed gap assessments to prepare them for the next phase of development and helped them to revise their QMS and Policies/Procedures to move development forward. The bulk of my pharmaceutical clients have been working in oncology and/or rare diseases.

Relevant Therapeutic Areas

  • Oncology
  • Rare diseases
  • Dermatology
  • Gastroenterology
  • Metabolic disorders
  • CNS
  • Hematology
  • Infectious diseases

Product Technologies

  • Drug
  • Small Molecules

Recent Titles

  • Director, Quality Assurance & Training Development
  • Senior Director, Clinical Operations & Quality Assurance


  • Mid-Atlantic Region
  • Open to remote, travel, and in-office

Relevant Companies

  • PRA Health Sciences
  • Johnson & Johnson
  • Small & Medium-Sized Biotechs

Skills & Accomplishments

  • 20+ years of experience in pharmaceutical, medical device, biologic and clinical trial industries
  • Global QMS, GMP, GLP, GCP, GCLP, GVP and REMS audit expertise
  • Extensive knowledge of global GCP, GMP, GLP regulations and ISO standards
  • QMS development and implementation