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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:

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 functional group head.

Qualifications

Education:

+ A Bachelor of Science (BSc) or equivalent degree is required

Experience/Skills

Required:

+ Minimum of 6 years of relevant work experience in quality/compliance environment

+ Excellent communication and presentation skills are required, ability to communicate professionally, concisely and effectively at various organizational levels.

+ Change management and stakeholder management skills

+ Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks

+ Ability to write and speak in English.

+ Expert knowledge of quality and risk management terminology and proficient knowledge of scientific terminology

Preferred:

+ Working knowledge in global GxP compliance regulations governing clinical development activities

+ Experience with quality and compliance metrics

+ Practical experience in understanding customer and business partner needs and implementation of change management

+ Global experience working with multidisciplinary and cross functional leaders from R&D, Medical Safety, Regulatory and Quality functions

+ Experience of successfully working in a heavily matrixed organization

+ Strong networking and relationship building skills and ability to collaborate in a multinational environment

+ Proficient in Microsoft Office applications (e.g., TEAMS, PowerPoint, Excel)

+ Experience in COMET application

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.

\#LI-Hybrid

Required Skills:

Preferred Skills:

Analytical Reasoning, Analytics Dashboards, Collaborating, Compliance Management, Data Gathering Analysis, Data Quality, Incident Management, Performance Measurement, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Risk Management, Systems Analysis, Systems Integration, Tactical Planning, Technical Credibility

The anticipated base pay range for this position is :

$102,000 to $177,100

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits