Manager, External Quality, External Laboratories; ECL) Americas

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Quality

Quality Assurance

Professional

Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

We are searching for the best talent for a Manager, External Quality, External Contract Laboratories (ECL) Americas located in either Horsham, PA, Malvern, PA or Raritan, NJ.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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• Drives Quality Assurance, Compliance and Technical Support for External Quality contract laboratories (ECLs) within the Pharma R&D organization and Janssen Supply Chain, primarily in North America and Latin America regions.

• This position serves in teams or major cross-functional project initiatives at the Divisional and the J&J company wide level with regard to management of the external contract labs used globally. Closely works together with other J&J sectors leads for external contract labs, Internal JSC-QC Lab representatives, DPDS, Site Quality leads, Product Quality management, Global Quality Lab Systems, Global Procurement and other stakeholders.

• Supports the EQ-ECL function Leader in the selection, development and management of External Contract Labs globally.

• Responsible for the end-to-end Quality and Compliance oversight of external contract laboratories (ECLs).

• Supports and implements the strategy for continuous improvement of the external contract lab management processes.

• Supports the Pharma consolidation plan of external contract labs within DPDS and JSC-QC labs including increased usage of Preferred Partner networks.

• Active role in the support of new company acquisitions’ onboarding of new ECLs, and associated Q&C remediation efforts, where the Manager will work closely with the various EQ, PQM, DPDS and JSC-QC/QA groups towards effective and timely qualification, and resolution of issues that may surface.

• Lead qualification activities of ECLs, by performing on-site and remote audits, develop corrective action plans to remediate deficiencies.

• May be involved in quality oversight for day-to-day ECL activities, primarily deviation and CPA management (e.g. Vaccines). Will support escalations, as required.

• Manage all utilized systems to ensure deviations are closed in time for release and stability.

• Independently solve issues as well as solving issues with key stakeholders like Subject matter experts from Analytical development or other EQ Account owners.

• May partake in the Vaccines or other platform programs’ Q&C initiatives at the ECLs.

• Apply cGMP…