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Johnson & Johnson is currently recruiting for an Enterprise Quality- IT Monitoring Manager! This position will be located in Raritan, NJ!

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/.

Key Responsibilities:

Defining, Enhancing, and Managing the Continuous Monitoring & Improvement Operating Model

• Responsible for developing and executing the strategy and framework for the TQ Continuous Monitoring process, which includes establishing and optimizing appraisal models, executing thorough CSV appraisals of IT systems (including infrastructure, applications, and healthcare technology systems), measuring and communicating results, and driving Continuous Process Improvement (CPI) initiatives based on data-driven insights.

• Responsible for executing TQ assessments and remediating IT systems originating from acquisitions with a strong focus on Computer System Validation best practices to ensure compliance with regulatory requirements.

• Ensures consistent execution across the TQC organization while continuously improving TQ&C processes through thorough data analysis and insights from validation outcomes and assessments.

• Conducts detailed assessments of in-scope systems and processes, identifying potential gaps, raising appropriate Non-Conformance reports, initiating CAPA, and driving remediation initiatives in alignment with business and IT goals.

• Establishes yearly plans for monitoring assessments and improvements, incorporating data analysis to inform decision-making.

• Applies expert knowledge of quality risk management practices to develop, mentor, and influence others in compliance with global processes, specializing in Computer System Validation (CSV) methodologies.

• Provides support for presenting and defending defined processes during internal assessments and health authority inspections, emphasizing the data-driven results of validation efforts.

• Tracks and documents quantifiable business results achieved from project work, leveraging data analytics to write success stories that demonstrate the business value created by TQ&C.

Stakeholder Management

• Effectively communicates assessment findings and their impacts through data insights to stakeholders at all organizational levels.

• Influences upward and across teams to ensure TQ&C processes are executed consistently, meeting compliance and regulatory requirements through clear data-driven narratives.

• Provides TQ guidance and support to project and base business support teams to ensure data consistency and reliability in process execution.

Other Duties & Responsibilities

• Develop and maintain effective working partnerships with senior management, integrating data insights into strategic discussions.

• Collaborate with leaders and staff within the Technology Quality and Compliance group to execute efficient operations focused on CSV.

• Ensure adherence to the TQ&C Operating Model while utilizing insights for continuous improvement.

• Ensure timely reports on status, metrics, and timesheets as required by the Technology Quality and Compliance organization, integrating relevant data insights.

• Ensure the timely completion of assigned training and expense reports related to CSV initiatives.

Required Knowledge, Skills, and Abilities:

Leadership Competencies

• Cross-Boundary Collaboration: Identifies opportunities for connection across team, functional, organizational, and geographical boundaries to achieve common goals through data-sharing practices.

• Productive Communication: Plans and relays ideas and insights to others in an impactful and productive manner, particularly when conveying data findings and improvement opportunities.

• Influencing: Understands stakeholder needs and takes a confident, empathetic approach to drive data-informed changes in actions and opinions.

Professional Competencies

• Problem Solving: Utilizes data to ask relevant questions, collect insights, and understand situations; proactively addresses potential issues based on data analysis.

• Critical Analysis and Decision Making: Gathers and analyzes data effectively to inform decisions in complex and challenging situations.

• Customer Centricity: Understands stakeholder needs and prioritizes efforts based on data-driven insights that reflect business impact.

Core Technical Competencies

• IT and Quality Frameworks: Knowledgeable in IT and Software Quality Frameworks applicable to quality and validation work (e.g., SDLC, GAMP5, CICD, ITIL) with a focus on CSV and data integrity.

• Quality Strategy (Applications and Infrastructure): Designs and maintains quality within technology solutions, integrating data analysis to assess compliance and effectiveness.

• Quality Management Systems: Understands and implements effective quality management systems, utilizing data insights to manage compliance across technology solutions.

• Data Analytics and Insights: Applies data science principles to conduct analyses from various data sources to measure the effectiveness of TQ&C solutions and drive continuous improvements in processes.

Qualifications

Education:

A Bachelor’s degree in Computer Science, Information Systems, Business Administration, or another related field is required; advanced degree preferred; relevant experience may substitute when appropriate; additional certifications in CSV and data analytics are a plus.

Required Skills:

• A minimum of 8-10 years of progressive experience in the pharmaceutical/medical device/biotech industry with direct experience in Quality/Compliance/Continuous Improvement, Computerized System Validation, and Data Analysis activities.

• Experience authoring or approving validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans, and Reports is required, with a strong emphasis on CSV documentation and analysis.

• Proven expertise in managing Global Validation programs and collaborating with global teams across multiple geographies, emphasizing data-driven insights for best

Other:

•This position has an estimated annual salary of 100,000 to 172,500 USD$

• 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:

• Vacation – up to 120 hours per calendar year

• 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

• Holiday pay, including Floating Holidays – up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]