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

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