Sr Specialist, 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:
Athens, Georgia, United States of America, Horsham, Pennsylvania, United States of America, Tampa, Florida, United States of America, Titusville, New Jersey, United States of America

Job Description:

Janssen Supply Group, LLC, a member of Johnson & Johnson Innovative Medicine, is recruiting for a Sr.

Specialist, External Quality (Small Molecules).

The preferred location for this position will be in Horsham, PA or Titusville, NJ.

However, the role can also be located in Athens, GA or Tampa, FL.

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/.  

In this position you will provide end-to-end quality support for external manufacturers and strategic partners, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.

Key Responsibilities:


* Provide quality and technical support to ensure effective execution of quality systems at external manufacturing sites.


* Support the identification and resolution of quality issues and complaints, including review and approval of non-conformances and development of robust CAPA plans.

Support the escalation and issue management processes.


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


* Monitor quality performance through key performance indicators; analyze data to identify risks and drive implementation of mitigation plans.


* Build relationships with internal and external partners to meet patient supply requirements.


* Support external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture.

Support risk management initiatives necessar...