Head of JJRC Technology Regulatory Compliance

Company: Disability Solutions
Location: Raritan
Posted on: September 14, 2023

Job Description:

Johnson & Johnson Services Inc. is recruiting for a Head of JJRC Technology Regulatory Compliance 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 $94.9 billion in 2022 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 Head of JJRC Technology Regulatory Compliance is responsible for leading a global team and building strong compliance capabilities and culture in the specialized areas of Technology. The position is responsible for GxP compliance strategy and operational excellence; serving as compliance key advisor and subject matter expert to business partners; enabling compliant innovation and growth; and shaping the external regulatory environment. This position is responsible for setting the overall strategy and direction for Technology Regulatory Compliance, including establishing and overseeing compliance programs covering GxP computerized systems, Cloud computing / virtualized data centers, big data, artificial intelligence, and other emerging technology areas. This position is instrumental in helping to identify, escalate, and manage risks and serves as a member of the JJRC and Technology Quality & Compliance leadership teams. This position reports solid line to the VP J&J Regulatory Compliance, within the Johnson and Johnson Regulatory Compliance (JJRC) organization. Key Responsibilities:

• Leads a globally dispersed specialized team, within a matrixed organization, to support a shared services organization that provides services to all Johnson & Johnson business units.
• Identifies and develops talent to meet the needs of a fast-paced innovation environment and new business models.
• Partners with Quality and other stakeholders to develop and deploy compliance strategies and frameworks for a broad range of innovative and emerging domains.
• Conducts business planning activities, including resource planning and budget planning.
• Develops business cases to support resource needs and capital investment.
• Engages with senior J&J Technology Quality & Compliance and J&J Technology leadership, across multiple functions, to serve as compliance advisor and subject matter expert for GxP activities related to computerized systems, Cloud computing / virtualized data centers, big data, artificial intelligence and other emerging technology areas.
• Owns and governs the execution of compliance programs, including J&J Technology- Technology Services (JJT-TS) Internal Quality Audit; Technology Supplier Audit (due diligence and surveillance); GxP System Periodic Reviews; Standards Management; Follow-up Programs; Data Center Inspection Readiness; Sector Inspection support; and Compliance metrics and analytics.
• Understands JJT-TS compliance risk profile, based on compliance programs and other intelligence (e.g., escalations, regulatory inspections, etc.), to proactively identify, communicate, prioritize, address, and manage risk.
• Provides expertise in evaluating and interpreting regulations at a global level and provides leadership in the identification of risk mitigation strategies.
• Provides leadership and strategic direction for interactions with regulators on matters related to technical topics; ensures subject matter expert preparedness; and reviews communications with Health Authorities.
• Engages externally with industry groups and regulators to shape emerging regulatory policy and partners internally with JJRC-Enterprise Regulatory Outreach and Regulatory Affairs to continuously monitor the changing climate and proactively assess and communicate trends and emerging areas. Owns strategic direction of Technology related regulatory outreach and associated activities to ensure alignment with business priorities. Leads the development of industry comments to proposed specialized regulations and guidance.
• Creates and deploys compliance strategies, including authoring position papers, to enable compliant innovation in emerging areas.
• Partners with Quality and other stakeholders to develop and deploy compliant digital technology strategies and frameworks.
• Provides partnership, insight, and direction to cross-functional business leaders and stakeholders regarding TRC processes, capabilities, and initiatives.
• Serves as compliance partner to Technology and Technology Quality, providing base business advisory expertise and in the creation of compliance strategies that enable innovation in emerging areas.
• Establishes and drives sustainable Technology compliance programs for new technologies.
• Supports strategies and practices to establish a continuous learning culture that supports talent capabilities, including future readiness and retention. This includes targeted technical and business process trainings, guided learnings, compliance retrospectives, new/changing regulatory Guidances/positions/enforcement trend debriefs, and allocation of talent with specific development/exposure goals (e.g. SaMD, Cybersecurity, etc.) for "ride along or second chair" as part of the Demand & Supply Intake Process.
• Contributes to talent pipeline efforts focused on identifying internal and external candidates with a niche skillset in compliance and technology for future TRC roles.
• Supports new talent on-boarding.
• Manages global teams across geographies including FTEs and Contractors within a matrixed organization.
• Responsible for the development of direct reports by supporting the development of Human Resources Planning (HRP) programs including management development and training to meet current and future business needs.
• Provides an environment which encourages the company's credo, commitment to equal employment opportunity and the value of a diverse work force.
• Conducts performance reviews, succession planning, talent reviews and career development for direct reports.
• Supports JJRC enterprise initiatives and working teams and supports execution of ERC independent audits and special investigations.
• Reviews and provides input to quality and/or technical standard changes to ensure continued compliance with health authority regulations.
• Ensures timely reporting of status and metrics as required by the JJRC organization.

Keywords: Disability Solutions, New Brunswick , Head of JJRC Technology Regulatory Compliance, IT / Software / Systems , Raritan, New Jersey