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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:

Digital Quality

Job Category:

Professional

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Horsham, Pennsylvania, United States of America, Irvine, California, United States of America, Jacksonville, Florida, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, Tampa, Florida, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Manager, Strategy & Risk Assessment! This position can be located at any J&J innovative medicine site with a preference for Raritan, NJ.

_Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):_

North America- Requisition #R-012330

Beerse Belgium– Requisition# R-013801

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

_At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity._

Position Summary:

The Leader, Technology Regulatory Compliance – Strategy & Risk Assessment is responsible for designing and implementing compliance strategies in specialized and emerging technical areas, such as regulated mobile medical applications, networked medical devices and medical device cybersecurity, software as a medical device (SaMD), big data, machine learning/artificial intelligence, blockchain, IoT, intelligent automation, quantum computing, and other emerging technical areas. The role is also responsible for designing, implementing, and executing a risk sensing framework that creates holistic view of complex risk factors across the global enterprise and drives risk based internal audit, supplier audit, and GxP System Periodic Review Program focus and scheduling. Responsibilities include:

+ Leadership, development, execution, and continuous improvement of J&J Enterprise Quality (EQ) global compliance programs.

+ Understanding global regulatory expectations and interpreting regulatory direction and guidance related to emerging digital innovation and platforms.

+ Using expert knowledge of regulations, technology, and risk control frameworks to develop tailored approaches for internal audit, GxP System Periodic Review, and supplier (software and technology service providers) audit programs that identify specific risk scenarios.

+ Designing, implementing, and executing a risk sensing framework that creates holistic view of complex risk factors across the global enterprise and enables TRC risk based internal audit, supplier audit, and GxP System Periodic Review Programs.

+ Authoring strategy documents and position papers to help guide compliant methods and control frameworks for adoption of new technologies in a GxP regulated environment.

+ Maintaining knowledge of strategic digital initiatives and major innovation programs across J&J globally and serving in a compliance strategy advisory capacity in the development of compliant pathways that meet regulatory requirements.

+ Execution of closed loop audit and assessment programs, including Technology Supplier Audit and GxP system Periodic Reviews.

+ Actively engaging with external advocacy groups to shape emerging global regulations in these areas and leading commenting to proposed regulation.

+ Leading inspection readiness for specialized technical areas.

+ Leading TRC Talent Development initiatives, such as training on methods for executing specialized audits and pre-implementation reviews related to emerging technologies.

+ Contributing to Knowledge Management content development for existing and emerging technologies.

This position will partner with JJT-Technology Services, Enterprise Quality, and business Sectors to ensure that J&J quality standards and global regulatory requirements are met and will support integration of new or changing regulatory requirements into the JJT-TS QMS as part of the Standards Management process. This position will serve as the compliance partner to Enterprise Quality – Digital Strategy Pillar Leaders to develop fit-for-purpose strategies that enable high quality, compliant systems for internal and external facing solutions and new health platforms.

This individual will report directly to the Head, Technology Compliance – Med Tech & Emerging Compliance within Johnson & Johnson Regulatory Compliance (JJRC).

+ Creates Quality & Compliance strategies, including authoring strategy documents and positions papers, to help guide compliant methods and control frameworks for adoption of new technologies in a GxP regulated environment.

+ Serves in a compliance advisory capacity to the Enterprise Quality – Digital Strategy Pillar Leaders, JJRC Enterprise and Sector Compliance groups, and Sector Quality organizations in the development of compliant pathways for new technologies that meet regulatory requirements.

+ Researches and understands risk factors related to specific technologies and uses expert knowledge of regulations, technology, and risk control frameworks to develop tailored approaches for internal audit, GxP system Periodic Reviews, and supplier (software and technology service providers) evaluation to identify relevant risk scenarios.

+ Leads and executes specialized periodic reviews/internal/supplier audits, as well as pre-implementation reviews, related to emerging technologies.

+ Executes closed loop Supplier Audit and GxP System Periodic Review Programs, including conducting independent audits/reviews, providing independent oversight of audit planning, execution and tailored assessment/fieldwork approaches, audit and assessment corrective actions, documenting results, reporting on follow-up status, escalating critical issues/risk to senior leadership, performing trend analysis, and continuously improving program effectiveness.

+ Executes technology inspection readiness and support program, including providing support to J&J Operating Companies globally and preparing technical subject matter experts to interface with regulators. Strategizes the approach for regulatory interactions and engages directly with health authority agencies during inspections. Leads the development of responses to Technology owned health authority observations.

+ Translates technical and compliance risk into business impact and escalates critical issues to senior leadership when appropriate.

+ Provides leadership and support to IT and Quality groups in the development of corrective action plans that systemically address the root cause of issues and leads execution of corrective action verification activities, including status reporting, in support of closed loop audit programs.

+ Trains TRC personnel and strategic partners on specialized audit approaches and methods for emerging technologies to support talent development and risk management objectives.

+ Actively engages with external advocacy groups, as well as J&J liaisons on external advocacy groups, to shape emerging global regulations in these areas. Interprets, benchmarks, and implements industry trends and best practices within TRC compliance program. Participates in commenting to proposed regulation.

+ Contributes to Knowledge Management content development and serves as compliance subject matter expert for emerging technologies regulation.

+ Supports integration of new or changing regulatory requirements into the JJT-TS QMS as part of the Standards Management process.

+ Partners with IT, EQ, and Sectors to execute inspection readiness activities and ensure subject matter expert preparedness. Provides leadership and strategy for interactions with regulators on matters related to emerging technologies topics.

+ Serves as a trusted partner across the Enterprise Quality organization and directly manages relationships with Enterprise Quality – Digital Strategy and IT Monitoring Pillar Leaders.

+ Applies comprehensive knowledge of global risk management practices to influence the evolution of Regulatory Compliance programs executed by TRC.

+ Owns design and development of a risk sensing framework, based on data driven predictive indicators, to enable a holistic view of complex risk factors. This framework will drive a risk-based approach to development of annual internal audit, supplier audit, and global enterprise (Innovative Medicine, MedTech, and IT) GxP Computerized System Review program plans and focus areas.

+ Manages the execution and continuous improvement of the risk assessment process, including owning related data (e.g., risk register outcomes) to support scheduling decisions. Develops and maintains the audit program schedules based on risk assessment results

+ Leads and coaches TRC through the risk management lifecycle, including yearly and quarterly data analysis and audit/assessment program plan development. Sets targets for risk management activities and proactively delivers against risk management initiatives.

+ Leads review of risk indicators with senior leadership, including Head of TRC and his leadership team, and gains alignment to audit/assessment plans.

+ Interprets Health Authority observations/guidance/enforcement actions to determine if changes are required to maintain the effectiveness of the risk sensing framework.

+ Leads development of creative dashboards, visualizations, analysis report, algorithms, and risk management tools for use across the EQ organization.

+ Promote ideal practices for risk metrics & measurement and help make data more accessible and meaningful and drive the end-to-end delivery of platforms to supervise, visualize, and optimize risk management and measurement.

+ Engages directly with health authority agencies during inspections to explain and defend risk assessment practices that lead to audit entity selection.

+ Drives and oversees responses to Technology Services owned health authority observations.

+ Maintain up-to-date and emerging knowledge of compliance processes and changes (real-time occurring or imminent).

Other:

+ This position may require up to 25% domestic & international travel.

+ This position has an estimated annual salary of $120,000-$207,000  $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

The anticipated base pay range for this position is :

$120,000-$207,000

Additional Description for Pay Transparency:

• This position has an estimated annual salary of $120,000-$207,000  $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