Senior Manager, Quality Assay Validation

Jobgether • United States

Remote

This Job is No Longer Active This position is no longer accepting applications

AI Summary

Lead quality oversight for analytical methods and testing systems, ensuring regulatory, GMP, and commercialization requirements are met. Collaborate with internal teams and external partners to support analytical readiness, product quality, and inspection preparedness. Contribute to global public health initiatives within an innovative and collaborative environment.

Key Highlights

Lead quality oversight for analytical methods and testing systems

Collaborate with internal teams and external partners to support analytical readiness, product quality, and inspection preparedness

Contribute to global public health initiatives within an innovative and collaborative environment

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Key Responsibilities

Serve as a key quality partner responsible for ensuring analytical methods and testing systems meet regulatory, GMP, and commercialization requirements

Lead quality oversight for assay validation, analytical method transfers, verification activities, comparability assessments, and lifecycle management across development and commercialization programs

Review and approve validation protocols, reports, transfer documentation, analytical control strategies, specifications, and lifecycle management records

Technical Skills Required

GMP quality experience Analytical method validation Lifecycle management

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Benefits & Perks

Competitive annual salary range of $120,000 - $148,000

Fully remote work opportunity

Comprehensive medical, dental, and vision insurance coverage

Job Description

This role provides strategic quality leadership for analytical assay validation and lifecycle management activities supporting vaccine development programs.The position plays a critical role in ensuring analytical methods are robust, compliant, and ready to support clinical, regulatory, and commercial milestones.Working across cross-functional teams and external laboratory partners, the role helps advance products from development through commercialization.The successful candidate will provide GMP oversight, strengthen analytical systems, and support regulatory submission readiness.

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