Kelly Fenner

About Kelly Fenner

High performing and motivated professional with 20 years experience in the pharmaceutical industry and clinical laboratory settings. I have held compliance positions with increasing responsibility in the areas of risk management, quality, compliance and training. My most recent compliance/quality focus has been in the area of quality risk management. I am a competent GCP/quality subject matter expert providing guidance to clinical research and development teams regarding SOPs, company policies, GCP requirements/regulations and have also served in the capacity to review clinical trial processes to ensure conformance with company policies, and GCP/regulations. I have prepared clinical teams for sponsor-monitor regulatory authority inspections, including FDA, EMEA and PMDA and served an active role in the staging room as a QC function during the inspections.

Experience

1. Global Site and Study Operations Process & Standards Lead

   Pfizer

   Dec 2018 — Present

Education

• University of the Sciences in Philadelphia

  BS, Medical Technology

  1992 — 1996

• Temple University

  Master of Science, Quality Assurance/Regulatory Affairs

  2002 — 2004

Skills

• Infectious Diseases
• Microbiology
• Clinical Development
• Pharmacovigilance
• Quality Control
• Good Clinical Practice (Gcp)
• U.s. Food and Drug Administration (Fda)
• Ich-Gcp
• Quality Auditing
• Clinical Trials
• 21 Cfr Part 11
• Pharmaceutical Industry
• Sop
• Fda
• Immunology
• Clinical Monitoring
• Quality Management
• Regulatory Submissions
• Oncology
• Protocol
• Therapeutic Areas
• Ctms
• Clinical Research
• Capa
• Standard Operating Procedure (Sop)
• Gcp
• Regulatory Requirements
• CRO