Senior Manager External Quality

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 https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Manager External Quality! This position can be located at any J&J Internal Medicine site in the US, with a preference for New Jersey or Pennsylvania.

In this position you will be responsible for providing quality leadership and oversight of external manufacturers in the North America region, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.

Key Responsibilities:


* Ensure effective and compliant execution of quality systems at external manufacturing sites


* Participate in the selection, qualification, and ongoing monitoring of external partners


* Provide leadership in the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans


* Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies


* Monitor quality performance through the development of key performance indicators


* Lead the identification of risks along with the development and implementation of mitigation strategies


* Build relationships with internal and external partners; Influence external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture


* Collaborate with EMs to support health authority inspections; monitor and follow-up on associated commitments


* Provide oversight for technology transfer and new product introduction activities; lead PAI readiness and support associated health authority filings and approvals


* Partner with key internal stakeholders in support of supply chain to meet patient supply requirements


* Assess current quality systems and recommend improvements to improve compliance and optimize processes


* Provide mentoring, coaching, and training to direct reports or team members to support organizational development

Qualifications

Education:

A minimum of a Bachelor’s or equivalent University Degree is required with a focus in eng...