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

Johnson Johnson; Horsham (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, External Quality for External Contract Laboratories (ECL) Americas, based in Horsham, PA, Malvern, PA, or Raritan, NJ. You will lead QA activities, ensure cGMP compliance, oversee audits and qualification of ECLs, and collaborate with Global Quality and DPDS teams.

The role covers end-to-end quality and compliance oversight of external labs, risk assessment, CAPA, and development of quality agreements, with travel to audit sites as needed.

Qualifications

• Quality Assurance
• cGMP knowledge
• Auditing experience

Responsibilities

• Lead QA activities for External Contract Laboratories (ECLs).
• Oversee audits and qualification of ECLs.
• Develop and implement quality agreements with external labs.

Job description

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 MedTech, 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. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

Professional

All Job Posting Locations

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

Job Description

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 .

About Innovative Medicine

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.

Learn more at https://www.jnj.com/innovative-medicine

Purpose

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 companywide 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 regulations, FDA and international requirements to all aspects of the position. Ensure timely and proper reporting to partners and stakeholders. Position may require flexibility in working schedule on occasion, in order to provide cGMP assistance and quality oversight. Responsible for development, negotiations, execution and maintenance of Quality Agreements with the different External Contract Laboratories. Pro-actively identify risks at the external contract labs, elevate critical to quality issues in a timely manner and lead resolutions. Monitors compliance of external contract labs through tracking and trending metrics resulting in up-to-date Risk Register. Drive periodical Business Review meetings with preferred external contract labs in order to review strategy; metrics; expectations; share best practices; business acumen; further integration with Janssen Quality Systems. Implement the yearly external contract lab audit schedule and receive approval of site auditors to participate within the audit program. Travel to External Contract Lab sites to conduct audits, provide cGMP assistance and quality oversight.

Qualifications / Requirements

A minimum