NA Sr Manager QS and Perf Monitoring

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:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Toronto, Ontario, Canada

Job Description:

Johnson & Johnson is currently recruiting for a NA Sr Manager QS and Perf Monitoring, located in Raritan, NJ, Titusville, NJ, Horsham, PA or Toronto, Canada!

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/.

The Regional Sr.

Manager Quality Systems and Performance Monitoring is responsible to assess the health and performance of the NA Quality Systems on behalf of the US and Canadian Janssen commercial companies.

This includes:


* Quality System Management Review (QSMR) Lead for the North American Region including commercial businesses of all therapeutic areas for both US and Canada.

Continuously assess the health and performance of the QMS and identify high risk areas, work with business partners in CQ NA to address with CAPA where appropriate.

Specific areas of responsibility include:


* Analyze and report US and Canada Quality System metrics


* Prepare and lead CAPA Review Board meetings


* Implement and continuously evaluate the quality systems as per current US and Canadian GxP requirements


* Understand North American LOC including US and Canada needs related to quality system and processes

What You Will Do:



* Coordinate the QSMRs for the US and Canadian LOCs, providing in-depth data analysis of product information including complaint data.

Prepare annual Quality Review for Puerto Rico.

Ensure compliance awareness is highlighted and addressed in the QMR updates to the commercial boards.


* Serve as CQ NA lead on the QSMR/Metrics Community of Practice to ensure alignment across all regions and to introduce analytical improvements for data gathering and QSMR preparation.


* Support regional Commercial Quality organization and partner with other LOCs to build quality processes and maintain the compliance with J&J standards, ensuring identi...