Manager, External Quality, External Contract Laboratories (ECL) Americas

Johnson & Johnson

Johnson & Johnson seeks a Manager for External Quality overseeing contract laboratories across the Americas. The role manages quality assurance, compliance, and technical support for external labs supporting pharma R&D and supply chain operations, with responsibility for audits, corrective actions, and regulatory adherence.

Responsibilities

Conduct on-site and remote audits of external contract laboratories and develop corrective action plans
Manage quality agreements, deviation tracking, and compliance oversight for contract laboratory operations
Lead risk identification, escalation, and resolution for quality issues at external facilities
Drive business review meetings with preferred contract labs to align strategy, metrics, and best practices
Support acquisition onboarding, lab qualification activities, and cGMP compliance assistance

Requirements

Bachelor's degree in engineering, science, or equivalent technical discipline
Minimum 6 years pharmaceutical, medical device, or biotech regulated environment experience
Minimum 2 years pharma quality control or analytical development lab experience
Extensive quality assurance, quality control, and compliance background
FDA/EMA regulatory knowledge for biologics and pharmaceutical testing
Pharmaceutical quality management system experience
Ability to work independently and lead cross-functional global teams

Apply

Vacancy posted 2 days ago

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