Manager, R&D Escalation 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

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

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

We are searching for the best talent for Manager, R&D Escalation Lead to be located in Raritan, NJ or Horsham, PA.

The Manager, R&D Escalation Lead is accountable for the robust and fit-for-purpose execution of the Innovative Medicine (IM) R&D Escalation process of potentially significant Quality issues.  As such, the Manager drives the continuous oversight and improvement of the process and system performance, and supports the key users in the process with onboarding, training and process execution enablement.

The Manager will use measurement, analysis, and evaluation as means for continual improvement of the Escalations Process and will promote the achievement of quality objectives through key process indicators related to the objectives of the organization/QMS.

The position holder identifies the processes and process outputs that must monitored, identifies the parameters and outputs that allow to draw conclusions on process performance and related roles & responsibilities.

You will be responsible for:

• Drive the execution of an efficient and effective R&D Quality Issue Escalation governance program to accurately track and proactively manage the escalation process.

• Prepare and present relevant Escalation data at various governance forums where Escalation data is reportable, including support for Global R&D QSMR (Quality System Management Review).

• Lead independent monitoring on the state of the Escalation control, system health and to provide meaningful interpretation of trends and signals identified.

• Support audit and inspection readiness including ad hoc data requests for quality issue escalations in scope of IM R&D and OCMO.

• Develop and facilitate mechanisms/ processes to identify potential gaps or opportunities for improvement and recommendations to improve the escalation process and the management of potentially significant quality events across IM R&D and innovate ahead of industry standards.

• Partner with organizations, functions, standards & business process owners to drive strategies for quality and optimal process performance of GxP activities.

• Review effectiveness of dashboards and dashboard metrics to improve meaningful utility to owners, governance bodies and senior leadership.

• Maintain appropriate level of expertise in US and international GCP/GLP/PV regulatory requirements, policies, SOPs and unit/project-specific procedures applicable to the processes and systems within the scope of the IM R&D QMS. Ensure alignment and compliance to appropriate J&J Quality Standards, Standard Operating Procedures, Health Authority/Country Regulations and guidelines.

• Serve as Business Process Owner for R&D Quality Escalation process. Manage community of practice for R&D ELs (Escalation Leads) and QH (Quality Heads) with process-specific roles and responsibilities to fulfill. Manages User Access requests for users in the Escalation process IT system.

• Subject Matter Expert in the process, procedure, system and requirements for R&D Escalation. Participates in system design/enhancements definition activities required to support the process.

• Participate in other key projects as required in consultation with the functional line manager or f