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:

Legal & Compliance

Job Sub Function:

Enterprise Compliance

Job Category:

People Leader

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 Director, Technology Compliance! 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-012331

Beerse Belgium– Requisition #R-013811

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 Head Technology Compliance – Med Tech & Emerging Compliance is responsible for GxP Technology compliance strategy and operational excellence, including accountability for GxP System Periodic Review, Technology Services Internal Audit, Technology Supplier Audit, Audit Follow-Up, Standards Management, and Inspection Readiness and Support Programs. This position is responsible for working with Med Tech internal business partners and Technology Suppliers to enable the development of corrective and preventive actions related to audit and/or inspection findings and partners internally to develop compliance strategies that meet regulatory requirements. Responsibilities include design and ownership of a risk sensing framework to drive audit scheduling and focus; developing strategies and methods for assessing new/emerging technologies in specialized areas; and partnering with Technology Services, Enterprise Quality, and Med Tech Sector stakeholders to ensure that J&J quality standards and global regulatory requirements are met and will ensure integration of new or changing regulations into the business, including monitoring of implementation status. This position owns and continuously improves compliance programs, including audits/assessments, health authority inspection readiness, and external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions.

This position will partner closely with the Enterprise Quality – IT Monitoring Pillar Leader to develop and execute risk sensing compliance capabilities, and with the Enterprise Quality – Digital Strategy Pillar Leader to develop fit-for-purpose strategies that enable high quality, compliant systems for internal and external facing solutions and new health platforms.

This position reports solid line to the Head JJRC Technology Regulatory Compliance, within the Johnson and Johnson Regulatory Compliance (JJRC) organization.

• Defines strategies to move TRC towards a more positive risk management posture by utilizing knowledge of current and emerging regulations.
• Applies expert understanding of current and evolving regulations to continuously assess and evolve compliance programs and audit/assessment methods.
• Interprets Health Authority observations/guidance/enforcement trends to determine if changes are required to maintain the effectiveness of compliance programs.
• Translates compliance requirements into business and IT relevant terms for key stakeholders and gains support by articulating and promoting positive links between compliance and business impact.
• Maintains knowledge of business process area technology and strategic initiatives within span of responsibility and feeds that intelligence into risk assessment and risk management activities to prioritize audit/assessment scheduling and field work focus
• Drives the understanding of risk factors related to specific technologies and leads the development of tailored approaches for internal audit, GxP system Periodic Reviews, and supplier (software and technology service providers) evaluation to identify relevant risk scenarios.
• Understands JJRC, EQ, and JJT-Technology Services organizational strategies and integrates requirements into TRC G&O planning and roadmap to ensure alignment.
• Provides leadership and expertise in interpreting, evaluating, and classifying risk associated with audit findings.
• Coaches team on the planning/preparation, execution, and field work focus for audits/assessments.
• Provides leadership and support in the development of corrective action plans that systemically address the root cause of issues.
• Coaches and Leads team members in the execution of corrective action verification activities, including status reporting, in support of closed loop audit programs:
  • Technology Services Internal Audits
  • Technology Supplier Audits
  • GxP Computerized System Periodic Reviews
  • Health authority inspection commitments
• Escalates critical issues/risk to senior leadership and continuously improves program effectiveness.
• Analyzes audit and other compliance data to identify trends and insights to drive proactive quality actions.
• Leads development and oversees flawless execution of a risk sensing framework, based on data driven predictive indicators, to enable a holistic view of complex risk factors across the global enterprise and enable TRC risk-based approach to scheduling JJT-TS internal audit, JJT-TS and Sector/Enterprise technology supplier audit, and Sector/Enterprise GxP System Periodic Reviews.
• Leads review of risk indicators with senior leadership, including the VP, Enterprise Quality, and gains alignment to audit/assessment plans.
• Leads and coaches a team 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.
• Interprets Health Authority observations/guidance/enforcement actions to determine if changes are required to maintain the effectiveness of the risk sensing framework.
• Provides direct support to J&J Operating Companies globally during inspections, including preparation of technical subject matter experts to interface with regulators.
• Engages directly with health authority agencies during inspections.
• Supports the development and write-up of responses to Technology Services owned health authority observations.
• Serves as Technology audit/assessment process subject matter expert during internal audits and external regulatory inspections.
• Provides leadership and direction in the creation of Quality & Compliance strategies that guide compliant adoption of new/emerging technologies in a GxP regulated environment (e.g., AI/ML, externally facing digital health apps, etc.).
• Drives the understanding of risk factors related to specific technologies and leads the development of tailored approaches for internal audit, GxP system Periodic Reviews, and supplier (software and technology service providers) evaluation to identify relevant risk scenarios.
• Interprets and communicates current and emerging regulations at a global level and continuously monitors the changing regulatory climate to proactively assess and communicate trends and emerging areas.
• Leads the development and submission of industry comments to proposed regulations and Guidances.
• Partners with JJRC-Enterprise Regulatory Outreach and owns strategic direction of Technology related regulatory outreach and associated activities to ensure alignment with business priorities.
• 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 Enterprise 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.
• Creates and delivers regulatory compliance training and awareness programs to internal stakeholders.
• 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.

Other:

• This position may require up to 25% domestic & international travel.
• This position has an estimated annual salary of $146,000-$251,850 USD$
• 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

This position is eligible to participate in the Company’s long-term incentive program.

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 :

$146,000-$251,850

Additional Description for Pay Transparency:

• This position has an estimated annual salary of $146,000-$251,850 USD$ • 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 This position is eligible to participate in the Company’s long-term incentive program.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.