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, Malvern, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a 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.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress.

As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good.

We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.

Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

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, an...