Toni McBride, Director of Regulatory and Quality Assurance

Toni McBride

Director of Regulatory and Quality Assurance

As the Director of Regulatory and Quality Assurance at Life Science Outsourcing’s East Coast location, Toni McBride leads the development, management, implementation and sustainability of our ISO 13485:2016 Quality Management System, and ensures the effective implementation of those standards across the entire plant.

McBride also directs the effective implementation and execution of all quality assurance and improvement activities in compliance with LSO’s FDA registration under 21CFR Part 820, including the recent implementation of  LSO’s comprehensive electronic quality management system (eQMS) which linked all of LSO’s critical-to-quality functions though a comprehensive cloud-based control system.

Additionally, McBride is responsible for overseeing the regulatory compliance program and safety and risk management programs across the entire plant.

Most recently, McBride spearheaded the qualification and validation of LSO East’s in-house ethylene oxide (EtO) sterilization system, providing our customers a validated turnkey packaging solution from packaging design through sterilization and release

Toni McBride has over 25 years of operational and quality assurance expertise in the medical device industry, ranging from Manufacturing Manager to her current Director role with Life Science Outsourcing.  Her comprehensive, hands-on expertise with the entire value stream creates a top-down total employee engagement with the quality management system and ensures that LSO delivers exceptional products and services to our customers and their patients, each and every time.

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End-to-end solutions designed to accelerate time to market and reduce costs.

Life Science Outsourcing is an FDA-registered and ISO 13485-certified, performance-driven Contract Manufacturing Organization focused on assembly, packaging, sterilization, and diagnostics (wet reagent packaging). Our unique business model emphasizes in-house, end-to-end process and service offerings, coupled with deep regulatory knowledge. This provides the agility and flexibility necessary to accelerate go-to-market launches, while standardizing supply chain and mitigating risk.

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