Sr Manager - Product Risk Management

J&J Innovative Medicine a member of the Johnson & Johnson Family of Companies and is recruiting for a Sr. Manager Product Risk Management and Product Quality Management (PQM) Support ! This position can be located in any of the J&J Innovative Medicine sites such as Titusville, NJ, Horsham, Raritan, NJ, PA, Beerse, Belgium, or Leiden Netherlands Schaffhausen, Switzerland, Cork, Ireland, Leiden, Netherlands, Latina, Italy, Gurabo, Puerto Rico, Geel, Belgium!

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 Sr. Manager Product Risk Management and PQM Support is responsible for ensuring robust processes enabling effective implementation of risk management throughout product lifecycle with a key goal of producing high quality products and mitigating risks.

Key Responsibilities:

• Provides leadership and oversight to ensure the use of quality principles and tools to manage and optimize the robustness and consistency for Product Risk Management (PRM) processes.


• Provides strategic direction on the implementation of efficient PRM processes ensuring compliance and consistency with ICH Q9 and ISO 14971 risk management principles.


• Responsible for the deployment of PRM processes within J&J Innovative Medicine and resolution of process execution challenges through collaboration with internal customers.


• Leads and facilitates data driven product risk assessments to manage potential risk during development and commercialization.


• Engages in global councils and enterprise forums, ensuring PRM business needs are represented.


• Leads PQM operational improvement projects through structured project management methodology.


• Manages, coordinates, and provides oversight on assigned quality system processes as needed to support PQM.


• Influences through others to make the case for change and builds support for proposed solutions. Coordinates and drives implementation of continuous improvement and efficiencies through building positive relationships across functions, to meet unified business objectives.


• Partners with sponsors to obtain cross-functional and multi-site consensus and support for project activities, champions the usage and benefits of FPX and other project management approaches and mentors others on their effective application.


• Builds trust with others and seeks to discuss difficult issues or concerns openly and respectfully.