Uma IyerPharmexcellence, LLCA pharmaceutical/biopharmaceutical consultant in the quality compliance space with specific interest in helping clients: Build effective quality systemsOversee remediation effortsImplement quality improvement plansFormulate quality decisionsConsultationCreating/reviewing high level policy documentsPrepare for auditsCross-functional CommunicationProgram ManagementMentoring and Talent Development Consulting assignments heretofore include creating an IMPD, building quality systems for a virtual company in early clinical trials, and strengthening quality processes for a biologics manufacturer. Currently, serving as a program manager for a company to bring a Covid vaccine to market.Prior to consulting, Ms. Iyer held position as Quality Operations leader at Pfizer and prior to that at Warner-Lambert Company. She was responsible for managing all matters related to quality at multiple sites across the globe. This entailed ensuring the right people in the quality department at each manufacturing facility, succession planning, ensuring the robustness of the quality systems, availability of products to patients, regulatory compliance, review and endorsement of decisions related to critical deviations, implementation of electronic solutions for consistency in processes and access to data, and participating in leadership teams on the direction and strategy for the quality organization for the company.Her experience includes management of sites manufacturing sterile and non-sterile dosage forms, vaccines, and APIs across several time zones with varying regulatory rules and expectations and spans countries in Asia such as China, Japan, Korea, Singapore, Indonesia, Taiwan, India, and Australia, Central and S. America (Argentina, Brazil, Mexico, Venezuela), countries in the EU, and the US. Ms. Iyer holds a bachelor’s and a Master’s degree in Pharmacy from the University of Bombay and a Master’s degree in Management Science from the New Jersey Institute of Technology. Prior to retirement from Pfizer, Ms. Iyer was the Quality Operations Leader for Pfizer’s emerging market sites and served a year as the remediation for a Pfizer site coordinating the corrective actions arising from multiple regulatory audit commitments.