Sr Manager, Clinical Quality - Shockwave Medical - Remote

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:
Clinical Quality

Job Category:
People Leader

All Job Posting Locations:
New Brighton, Minnesota, United States of America, Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring a Senior Manager, Clinical Quality Assurance, to join our team! This is a fully remote role, with flexibility to be based anywhere within a reasonable commute to a major airport.

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/.

 Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.

Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Sr.

Manager, Clinical Quality Assurance will provide GCP and compliance-related oversight and audit of internal and external Clinical Studies in process, support and update procedure compliance with applicable regulations and oversee clinical affairs initial and ongoing vendor audits as needed.

This work is accomplished with minimal oversight, requires frequent contact with internal and external customers and is critical to the success of the business.

Essential Job Functions


* Act as a Clinical Quality Lead on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devices


* Develop and manage audit management plans and audit strategy for ongoing clinical trials


* Prioritize audit strategies for GCP programs


* Coordinate, plan and conduct internal system au...