What are the responsibilities and job description for the Manager External Quality - External Contract Laboratories - Americas position at Johnson & Johnson?
Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager External Quality - External Contract Laboratories - Americas located ideally in United States East Coast. Will consider other US location including remote US. Work location is flexible if approved by the Company except that position may not be performed remotely from Colorado.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we ae working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group, LLC, is part of the Janssen Pharmaceutical Companies.
The External Quality - External Contract Laboratories (EQ-ECL) is a key function involved in the selection, qualification, Q&C monitoring, and oversight activities of the Janssen’s global external contract laboratories network.
In this role, the Manager will be responsible to drive Quality Assurance, Compliance and Technical Support for External Quality contract laboratories (ECLs) within the Pharma R&D organization and Janssen Supply Chain, primarily in the Americas region (North America and Latin America).
This position serves in teams or major cross-functional project initiatives at the Divisional and the J&J companywide level with regards to management of the external contract labs used globally. Closely works together with others J&J sector peers 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. Will partake in the ongoing function Segmentation and Fit for Purpose initiatives as well as in the implementation of the function Strategy.
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 labs
- 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.
- 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, escalate critical to quality issues in a timely manner and leads resolutions.
- Monitor’s 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
- Bachelor’s degree in a scientific/technical discipline required
- Minimum of 8 years professional required with a minimum of 6 years experience working in an FDA regulated environment required
- Knowledgeable of FDA and/or EMA regulatory requirements applicable to biologics and/or pharmaceuticals’ testing required
- Experience working in Pharma Quality Control or Analytical Development laboratories preferred
- Experience in a Quality Assurance or Compliance related function preferred
- Lead auditor qualification preferred
- Ability to independently manage work to meet project objectives and timelines required
- Ability to work within multiple cross functional teams with global composition required
- Strong interpersonal and written/oral communication skills required
- Experience in using Pharmaceutical QMS systems, namely Trackwise/ETS or other related systems required
- Experience in audit participation required; experience leading audits preferred
- Good level of other regional languages (Portuguese or Spanish) preferred
- Up to 20% primarily domestic US; with some international travel may be required
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
United States-Pennsylvania-Horsham-200 Tournament Drive
Other Locations
North America-United States
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality
Requisition ID
2105926969W
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