Senior Director, Quality Risk Management & External Engagement (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 https://www.jnj.com

Job Function:
Finance

Job Sub Function:
Risk Management

Job Category:
People Leader

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, 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 (Raritan, Titusville, New Brunswick, Horsham) Req #: R-029351


* Belgium (Beerse) Req #: R-029481


* Switzerland (Schaffhausen, Basel) Req #: R-029469


* Ireland (Cork) Req #: R-029481


* Netherlands (Leiden) Req #: R-029481

Position Summary

The Senior Director, Quality Risk Management & External Engagement has oversight for the Regulatory Intelligence Programs in Clinical and Commercial Manufacturing (GxP, GMP, cGMP), Risk Management and Proactive Quality Planning functions for Innovative Medicine Quality & Compliance.

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 organization while enabling proactive alignment with emerging industry trends.

Key Responsibilities:


* Provide expert guidance on GxP compliance before, during, and after regulatory inspections, partnering with key stakeholders such as Regulatory Affairs and Compliance to facilitate effective communication with Health Authorities.


* 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.


* 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 within the R&D Quality team, establishing foundational risk gove...