Toyin Oladimeji
Sr Director, Quality & Regulatory Compliance @Thermo Fisher Scientific
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WORK HISTORY
Sr Director, Quality & Regulatory Compliance @Thermo Fisher Scientific
Washington, DC, US
Provide strategic leadership for global Quality and Regulatory Compliance programs across GxP functions, ensuring adherence to international health authority requirements (FDA, EMA, MHRA, etc.).Oversee quality systems including Deviations, CAPA, Change Control, and Document Management, driving continuous improvement and inspection readiness.Lead global compliance initiatives, harmonizing policies, procedures, and standards across sites to ensure consistent quality practices.Partner with cross-functional teams in Manufacturing, Quality Control, and Supply Chain to strengthen compliance and risk management strategies.Support regulatory inspections and internal audits, ensuring timely resolution of observations and sustainable corrective actions.Champion a culture of quality, accountability, and operational excellence throughout the organization.Provide leadership and guidance to regional and site quality teams, fostering collaboration, knowledge sharing, and regulatory intelligence.Engage with senior leadership on compliance metrics, emerging risks, and quality performance trends to inform strategic decision-making.
EDUCATION
University of Maryland
Master of Business Administration - MBA, Business Administration and Management, General
University of Missouri-Kansas City
Bachelor's degree, Chemistry
ABOUT TOYIN OLADIMEJI
Pharmaceutical professional with over 25 years of experience in operations, validation,quality, and regulatory compliance. Expertise in pharmaceutical manufacturing acrosscGMP facilities, including biologics, small molecules, and active pharmaceuticalingredients (API).Former FDA Drug Investigator skilled in conducting internal and external audits, supplierqualification, and regulatory inspections. Proficient in sterile manufacturing, riskassessment, deviation management, CAPA implementation, and ensuring adherence toindustry best practices.Expertise: FDA Regulations (21 CFR Parts 11, 210 & 211)EudraLex GMP GuidelinesPIC/S GMP GuidelinesICH Guidelines (Q7)(Q9) & (Q10)GxP Audit and GovernanceCompliance Remediation StrategyRegulatory Inspection StrategyData Integrity GovernanceQuality OperationsQuality Management System Protocol Development, Review and ExecutionQuality Risk ManagementDeviation Management Change ControlTechnical Knowledge: Aseptic process operationsPlasmid DNA & mRNA manufacturingEquipment and Utilities QualificationProcess ValidationSterilization ValidationCleaning ValidationTechnology TransferAnalytical Chemistry
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