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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 team, you will represent your function in support of core RDQ and business partner objectives and initiatives.

• **Serious Breach Office (SBO):** As a facilitator and record owner, you will adhere to the process and take ownership to drive the assessments and reporting of issues or events that are provided to the SBO for potential reportability to various Health Authorities.

Additional responsibilities:

• Ability to interpret problems, create proposals, and implement solutions that effectively address gaps and/or areas of potential improvements

• Manage projects with a high level of independence to ensure timely and accurate completion of activities

• Strong communication skills with a confirmed ability to effectively engage and balance key internal cross- functional internal and external business partners (including Health Authorities)

• Strong collaboration, alignment, and influencing skills with the ability to summarize and present results

Qualifications

• Bachelor's degree is required; preferably in a scientific, medical or related discipline.

• A minimum of 1-3 years of relevant experience working in the health care industry required; pharmaceutical, medical device or Biologics company experience is required.

• Experience in any GxP Quality Systems Management, Business Process Management and/or GCP Compliance functions preferred.

• Clinical trial experience is preferred.

• Strong project management experience and skills are required.

• Experience leading and influencing complex, cross-functional teams is required.

• Previous experience with fundamentals of clinical trial risk management and corresponding ICH guidelines is required.

• Proficiency with data visualization tools (i.e., Tableau, Spotfire, or related) preferred.

• Ability to collect, analyze, interpret and present collective data to enable data-driven decision making is required.

• A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication

skills required.

• Proficient in Microsoft Office Applications required.

• Travel ~10%- 15% primarily domestic and/or international required.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Clinical Risk Management, Cross-Functional Leadership, Data-Driven Decision Making, Data Visualization Tools, Project Management

Preferred Skills:

Audit Management, Business Alignment, Business Savvy, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Communication, Compliance Management, Data Analysis, Escalation Management, Fact-Based Decision Making, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Tactical Thinking, Vendor Selection

The anticipated base pay range for this position is :

94,000.00 - 151,000.00

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). • Employees are eligible for the following time off benefits: o Vacation – up to 120 hours per calendar year o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year o Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year • Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits