Leader, Strategy & Risk Assessment

Johnson & Johnson is recruiting for a Leader, Strategy & Risk Assessment, located in Raritan, NJ!

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.

With $76.5 billion in 2017 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

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.

Key Responsibilities:

• Leadership, development, execution, and continuous improvement of J&J Technology Quality & Compliance (JJTQ&C) 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.
• 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, Technology 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 Technology Quality – QMS & Enabling Platforms 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 Regulatory Compliance Operations & Strategic Enablement 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.
• Establishes strategy and sustainable execution plan for ongoing monitoring of digital assets, including externally facing health and mobile medical apps, and secures support and alignment from IT, MedTech, Pharm, and Enterprise to execute the strategy.
• Serves in a compliance advisory capacity to the TQ QMS & Enabling Platforms 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.
• 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, TQ, 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 Global Technology Quality & Compliance organization and directly manages relationships with Technology Quality - QMS and Enabling Platforms and Reliability & Operational Assurance 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 (Corporate, Pharm, 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 the VP, Global Technology Quality & Compliance 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 audit and periodic review program management, including yearly plan development, quarterly schedule review, and stakeholder management across IT, MedTech, Pharm, and Enterprise to negotiate alignment and secure support for audit and assessment plans across Sector and functional groups.
• Oversees audit and assessment Program execution in accordance with relevant Service Agreements and metric targets.
• Partners with Technology Quality leaders to ensure accuracy and completeness of the System Inventory for Global Quality IT systems to ensure compliance program effectiveness.
• Leads development of creative dashboards, visualizations, analysis report, algorithms, and risk management tools for use across the Technology Quality & Compliance 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.