Manager, External Quality, External Contract Laboratories (ECL) Americas Job at Johnson & Johnson, Malvern, PA

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  • Johnson & Johnson
  • Malvern, PA

Job Description

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

Job Tags

Contract work, Remote work

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