Controlled Substances Manager, Commercial 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:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, New Jersey (Any City), Pennsylvania (Any City), Somerset, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Controlled Substances Manager, Commercial Quality to join our team located in Titusville, NJ, with considerations given to Horsham, PA and other NJ/PA J&J sites at the discretion of the business.

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 https://www.jnj.com/innovative-medicine

Essential Job Duties and Responsibilities

The overall purpose of the Commercial Quality, Senior Manager/QA Associate Director for the US LOC is to ensure high quality products and services are available in every market every day.

Additionally, this role will support activities related to the Controlled Substance business within J&J.

The scope of Commercial Quality responsibility includes the Quality Management System within respective commercial businesses (i.e., Cardiovascular & Metabolism, Neuroscience, Immunology, Oncology, Pulmonary Hypertension, Infectious Disease & Vaccine, and Established Products) as well as quality and/or compliance within these Commercial businesses.

Key responsibilities include:


* Maintain QMS in U.S.

and continually evaluate and have oversight of the quality system for suitability and adequacy for the commercial business.


* Participate in escalations relevant to the US businesses that are SC led and lead CQ escalations, including root cause investigations, NC and CAPAs to mitigate risk.


* Continuously supervise the health of the QMS and identify high risk areas, address with CAPA where appropriate.


* Provide in-depth data analysis of product information including complaint data and review to support management review by providing recommendations for changes and updates to bring business value.


* Ensure all audit commitments are delivered on time


* Perform Know Your Customer ...