Jamie McCord

Senior Manager, Qa - Release @Novo Nordisk

Clayton, NC, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2024 — Present

Senior Manager, Qa - Release @Novo Nordisk

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Clayton, NC, US

Reporting to the VP of Quality, Jamie is responsible for leading the site Quality Assurance product release and quality systems for Drug Substance manufacturing including overseeing QA Risk Management from a DS quality perspective. Manage a team of senior quality specialists who oversee all quality management activities for product release and quality systems for the site including documentation support (Veeva), CoA generation, Emerson Syncade batch record review, Batch Release using digitalized batch release and manual batch disposition in SAP (ERP). Closely collaborate with internal (QA) and external (LoB) stakeholders to meet and continuously improve KPIs using LEAN methodologies. Lead and develop team through iterative target setting, task prioritization, performance management and devleopment. Provide coaching and lead regulatory inspections and internal audits with quality management team.

EDUCATION

2002 — 2007

North Carolina State University

Bachelors of Science

2025 — 2029

Temple University School of Pharmacy

Master of Science - MS

SKILLS

TitrationChemistryUvTissue EngineeringComputer System ValidationHplcPolymersDesign ControlPolymer CharacterizationQuality ControlChange ControlRaw MaterialsGmpPh MeterRegulatory SubmissionsEmpowerWet ChemistryNmrValidationCalibrationGas ChromatographyIrChromatographyChemstationLimsQuality SystemV&VPatentsCleaning ValidationGlpUspAnalytical ChemistryBiotechnologyBiomedical EngineeringMedical DevicesCapaTlcFtirTrainingR&D

ABOUT JAMIE MCCORD

Motivated by challenges and problem solving. Result driven. Detail oriented.

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Jamie McCord — Senior Manager, Qa - Release at Novo Nordisk in Clayton, NC, US | Unifers