CAPA Manager

Location: Spring House

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 Med Tech, 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  

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:*
* R&D Operations

** Job Sub*
* ** Function:*
* Clinical Trial Project Management

** 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

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* Job Description:

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* ** 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  

This is a remote and/or hybrid role available in New Jersey and Pennsylvania. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from various locations to apply and encourage you to review where this opportunity is available:

+ Horsham, PA

+ Malvern, PA

+ New Brunswick, NJ

+ Raritan, NJ

+ Titusville, NJ

We are searching for the best talent for a  
** CAPA Manager** .

The  
** CAPA Manager
** will support Delivery Units, and its Investigation Owners (IO) in the Corrective Action Preventive Action (CAPA) development and implementation process as a direct result of audits, inspections, and self-identified issues for both in-house and outsourced trials with a regional/global scope. He/she will oversee the Nonconformance/CAPA process and serve as the CAPA process expert for investigation owners through nonconformance identification, investigation, execution, and resolution.

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* Key Responsibilities:

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* + Act as CAPA Champion when regional/global roles in DUs are assigned as Investigator Owners of a nonconformance.

+ Act as process and system SME for the nonconformance and CAPA process and business/system requirements.

+ Assist the Investigation Owner in the application of structured problem? solving methodologies in Root Cause Analysis (RCA) investigations (Fishbone, 5 Whys, etc.) independently or in support of the Root Cause Investigation team.

+ Coach the Investigation Owner in understanding their end-to-end accountability of the entire CAPA process.

+ Develop and maintain proficiency in the COMET.

+ Work with the organization to identify resources to support RCA investigations and resulting actions.

+ Provide assistance to the Investigation Owner to ensure process requirements are met.

+ Monitor nonconformance and CAPA deliverables / timelines for functional area by running reports, communicating upcoming deadlines to record owners and escalating concerns to management as appropriate to actively drive compliance.

+ Act as a liaison between the IO and the quality leader; the IO and the Root Cause Analysis group; the IO and the Central Data Entry team.

+ Escalate any issues, as needed, to the R&D Quality CAPA Review Board and attend the meetings if required.

+ Raise any process or system questions or concerns to the CAPA Champions Community of Practice.

+ Collaborate with other CAPA Managers/Champions in the management of complex…