Senior Director, Quality Risk Management & Regulatory Intelligence (USA)

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Multi-Family Quality

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

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).

• USA Req#: R-062461

• Switzerland Req#: R-063952

• Belguim/Netherland Req#: R-063958

The Senior Director, Risk Management & Regulatory Intelligence  has oversight for the Risk Management and Proactive Quality Planning functions for Innovative Medicine Quality & Compliance as well as the Regulatory Intelligence Programs across GxPs. This position is critical to the strategic design and implementation of an effective and proactive Risk Management & Regulatory Intelligence framework to optimally prepare and support the Innovative Medicine Quality & Compliance (IM Q&C) organization while enabling proactive alignment with emerging industry trends.

Key Responsibilities:

• Oversee end-to-end risk management processes, ensuring comprehensive risk assessments, effective mitigation strategies, and continuous monitoring are implemented across the organization. Additionally, ensure that the organization possesses the necessary capabilities to conduct robust risk assessments.

• Integrate the Enterprise Risk Management (ERM) Framework through Predictive Risk Monitoring efforts across Innovative Medicine, establishing foundational risk governance.

• Build and lead a dedicated team that analyzes external industry trends and inspection outcomes to identify focus areas for improvement.

• Actively monitor and evaluate external industry trends, regulatory developments, and best practices, using this information to inform strategic decision-making across the business.

• Ensure that relevant information is proactively communicated to business partners and seamlessly integrated into audit and inspection readiness programs.

• Develop initiatives to integrate these insights into the Quality Management System (QMS) and operational procedures, ensuring alignment with industry standards and proactive risk mitigation.

• Conduct oversight activities across business units by applying risk-based methodologies to various risk types, including Health Authority Inspections, Audits, Compliance projects, and quality initiatives.

• Collaborate effectively to facilitate the deployment of compliance improvement initiatives and programs, including tracking the performance of remediation efforts and addressing associated risks.

• Coordinate independent confirmation and verification assessments, preparing a consolidated and actionable overview of risks related to remediation initiatives.

• Identify and evaluate opportunities for process improvement based on compliance and risk monitoring outcomes.

• Develop a comprehensive framework for evaluating key inputs while establishing an end-to-end governance process for assessing compliance and risk.

• Reinforce the importance of compliance and quality within the organization, ensuring the effective implementation of compliance strategies and our ability to detect and quantify risk appropriately.

• Serve as a key participant in industry forums and conferences to gain insights into emerging trends and developments within th