Driven, hardworking and enthusiastic quality assurance manager with proven success over 25 years at designing, implementing, and managing compliant and efficient strategies and systems (QMS, eQMS) across pharmaceutical, biologic, medical device, compounding & combination products. Committed to achieving goals while maintaining regulatory compliance.
Adept at interpreting regulations (FDA, HC, MHRA, EMA), Excellent reputation for resolving problems and improving customer satisfaction, experience hiring & developing individual team members, & Motivated to learn, grow and excel!
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, & ceased operations. Scope inclusive of small to large size organizations across, pharmaceutical, biologic, medical device, & compounding; organizations including, Baxter Healthcare Inc., AbViro LLC, Tanner Pharma Group Inc., Meridian Medical Technologies Inc., a Pfizer, Company, Kedrion Biopharma Inc.,Medicago Inc., Getinge Group Inc., PharMEDium LLC, IQVIA Inc., Zimmer Biomet Inc.
Provided strategic leadership & tactical & support for:
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