Director, Process & Personnel Qualification Management Lead

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/ .

Position Summary

R&D Quality is responsible for Quality and Compliance Oversight and related Risk Management for the Research and Development organization.

In that perspective, R&D Quality is intensively collaborating with key partners including the Therapeutic Areas, Global Development, Global Regulatory Affairs, and the Global Medical Organization along the development process, from discovery, pre-clinical, clinical, launch to post-approval activities.

The services and deliverables which R&D Quality provides to its key partners are the collaborative output of the different vertical organizational teams and are the result of interactions and partnership at different levels in the organization.

The Process and Data Management team is one of these vertical organizational teams, responsible for providing compliant, easy accessible process content, and for making learning tailored to the moment-of-need and at the point-of-use.

As Process & Personnel Qualification Management Lead, you will lead a global team of Process & Personnel Qualification Management experts (PPQM experts) overseeing the end-to-end delivery of process, qualification and training in the R&D Quality supported Quality Management System (QMS) framework, enabling dedicated Business Partners to conduct R&D/Medical Safety in an efficient and compliant way, resulting in programs that allow for seamless registration of the J&J innovative products.

The role will be setting the vision and strategy for process and personnel qualification management in collaboration with senior leaders in R&D functions.

The Director Process & Personnel Qualification Management (PPQM Lead) is a Leadership Team (LT) member of the Process and Data Management (PDM) department in R&D Quality.

This role serves as a single point of contact for senior management with business partners where the PPQM Lead is responsible for roll out and training of the overall applicable quality framework.

As an owner of the E2E procedural framework they are responsible for overall development of the PPQM strategy and ensuring Quality-by-Design principles are instigated in all PPQM deliverables.

The PPQM Lead is a member of the PDM LT and will collaborate with the other PPQM Leads of business units, PDM Head and other positions in R&D Quality to ensure an efficient and compliant QMS is delivered.

The PPQM Lead plays a strategic and operational role in coordinating the work of the PPQM team in a respective...