As part of the site leadership team, develop and lead site-wide human performance strategy to achieve excellence in execution.- Led team to apply human factoring principles & technical writing standards to MBRs and utilize human error prevention techniques; reduced human error by >70% in gene therapy drug product operations.- Developed and led human error prevention strategy to target batch loss reduction; trained and led team to conduct Human Reliability Analysis with Systematic Human Error Reduction and Prediction Analysis (SHERPA).- Implemented quality near miss program to support formal approach to actively seek and report error provoking conditions.- Provided site-wide human performance metrics to corporate.-Developed error prevention technique toolkit as part of the global human performance team.-Developed and implemented Job Observation Program to asses the performance gap (flawed defenses and error precursors) during task execution.

Highly sought leader, successfully exceeding deadlines, remediating GMP QMS, eQMS under challenging conditions; Consent Decree, Warning Letter, FDA Form 483, budget & personnel constraints, drug shortages, biologic, medical device, & compoundingdrug shortages, & ceased operations. Scope inclusive of small to large size organizations across, pharmaceutical, biologic, medical device, & compounding.

Self-driven, collaborative, strategic technical advisor to senior executive leadership; analyzed multiple product data sources for adverse trends to recommend a new risk-based product portfolio strategy & site metrics (KPI). Ensured effective CAPA closure, monitored & presented adverse trends to leadership- Coordinated remediation strategy between quality, operations, information technology (IT), training. Led eQMS implementation for deviation investigations, defined user requirements for process blueprint, developed procedures & corresponding training for newly designed eQMS.- Developed new communication process of audit observations across OTC division & corporate.- Advised, assisted QA Vice President (VP) & senior quality leadership in developing new site product portfolio to support reopening facility following successful 483 remediation.

In my role as a human performance model lead and Sr. QA specialist II at Pfizer, I received global recognition for reducing deviation and human error rates, implementing the human performance model from North America Commercial Nuclear, and supporting the transition to a new eQMS. I achieved 3 promotions in 8 years and was honored to present on error reduction to QA executive leadership, leading to the global implementation of HPM.

• Established new laboratory for analytical testing of multi-dose dry powder inhalers (particle size testing); managed test method transfers from UK to US• Designed & implemented Six-Sigma/Lean Manufacturing project; competency-based QC training program; North America • Trained by GSK Black Belt (GSK customized training Advocate Training considered equivalent to Green Belt by GSK)