Sr. Specialist, Process & Governance 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:

Clinical Quality

Job Category:

Professional

All Job Posting Locations:

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

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

The Clinical Risk Management-Operation Excellence (CRM-OpEx) Process & Governance Lead will be responsible for the Business Process Ownership of the CRM functions core processes, focusing on continual process improvement and the facilitation of data-driven operational governance. At 50% of their time, the incumbent will drive accountability in the implementation of the Research and Development Quality (RDQ) clinical trial risk management framework at Johnson & Johnson, ensuring effectiveness, compliance and transparency across therapeutic areas. As a contributor to the CRM-OpEx core accountabilities, the Process & Governance Lead will be allocated at 50% of their time to support of the Serious Breach pillar. #Li-Hybrid

Main Responsibilities:

·         Business Process Ownership (BPO): As the designated Clinical Quality Plan BPO, you will define, drive and enhance oversight strategies and monitoring capabilities to ensure the effectiveness and compliance elements of the CRM clinical trial risk management framework and Quality Support Services.

·         Performance Monitoring: As the Chair, facilitator or contributor to relevant Risk Management governance forums, you will develop, assess and report performance metrics related to quality, efficiency, and risk, identifying process and/or compliance strengths and gaps for management review.

·         Continual Improvement Driver: As a steward of continual process improvement, you will monitor adherence to implemented process controls, effectiveness and risk management requirements in alignment with associated business partner processes, enterprise standards and industry regulations to develop proposals for optimization initiatives.  You will identify and deliver key improvements to the Clinical Quality Plan process in collaboration with CRM, and key business partners.

·         Data Analysis and Visualization: As a presenter and primary monitor of CRM metrics and KPIs, you will collaborate with stakeholders to create and monitor meaningful digital dashboards that enable clear interpretation and data-driven decision making.

·         Leadership in Meetings: As a Chair of the CRM Governance forums and Serious Breach assessments, you will model the appropriate level of preparedness, executive presence, confidence and assertiveness to thoroughly to enable efficient, data-driven decisions and actions.

·         Collaboration: As part of the RDQ and broader J&J community, you will partner with RDQ QANA, R&D stakeholders and other potential sources of benefit from across IM and MedTech to develop templates, scorecards, and dashboards that simplify activities for functional teams and contributors.

·         Strategic Support: As a Leader within the CRM-OpEx t