Damián Bigio

Sr Manager Qa Laboratory Controls & Stability @Kenvue

Hillsborough, NJ, US

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Mar 2026 — Present

Sr Manager Qa Laboratory Controls & Stability @Kenvue

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Summit, NJ, US

Global contact for the requirements and processes related to laboratory controls and stability within Kenvue’s Global network of Quality Control (QC) Laboratories. Responsible for the development, maintenance and continual improvement of laboratory documentation and stability programs, including defining QC Lab control requirements, overseeing SOP development and governance, and owning standards for data integrity and stability testing across the Kenvue network.

EDUCATION

1991 — 1995

Universidad de Puerto Rico

Bachelor of Applied Science (BASc), Analytical Chemistry

SKILLS

Pharmaceutical IndustrySopFdaDissolutionComputer System ValidationLaboratory SkillsLaboratory Information Management System (Lims)LimsCapaHigh-Performance Liquid Chromatography (Hplc)Quality ControlHplcGmpUvGood Laboratory Practice (Glp)LaboratoryCleaning ValidationDeviationsLean ThinkingFormulationPoeChange ControlRaw MaterialsProblem SolvingUv/VisTechnology TransferCorrective and Preventive Action (Capa)Standard Operating Procedure (Sop)Regulatory RequirementsAnalytical Method ValidationValidationGlp21 Cfr Part 11GxpQuality AuditingChemistryU.s. Title 21 Cfr Part 11 RegulationTechnical Writing5sU.s. Food and Drug Administration (Fda)

ABOUT DAMIÁN BIGIO

Results-driven Senior Quality Leader with 15 years of experience leading cross-functional teams and managing quality systems in highly regulated global environments. Expertise in external regulatory compliance (FDA, Health Canada, ICH), and driving operational improvements that ensure product quality, safety, and regulatory adherence. Proven success in leading regional/global compliance projects, reducing operational costs, and optimizing processes to enhance efficiency. A strategic thinker with strong problem-solving skills and a track record of developing data driven innovative solutions that reduce waste, improve throughput, and drive continuous improvement.

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