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 governance.

• 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.

• 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.

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

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

• 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 the industry, which will inform strategic initiatives and ensure that the organization remains aligned with best practices and competitive standards.

Required Minimum Education: BS degree required. Masters or advanced degree in a scientific field (Life Sciences, Pharmacy, Engineering) desirable.

Required Years of Related Experience:

• Requires at least 15 years of experience with 5 plus years’ experience and demonstrated leadership in a quality function working on complex and significant compliance topics.

• Minimum 5 years of proven people leader experience

• Must have comprehensive knowledge of GxP, GMP, cGMP and IT compliance regulations and guidelines, with expert knowledge on US and EMEA Regulations

• Requires knowledge of latest auditing, investigation, and remediation techniques as well as leadership experience with inspections.

• Demonstrated effective influencing, interpersonal, written, and verbal communications skills as well as a proven track record of sustaining compliance in complex organizations.

• Regulatory Authority experience is desirable

• Experience with Regulatory Authorities is a significant asset

Required Knowledge, Skills and Abilities:

• Strong Quality and Compliance background with a deep understanding of Global GxP, GMP, cGMP requirements and the systems used to deploy them.

• Experience in the identification and management of risks, including the development of risk-based remediation strategies and reporting risks/status in a concise manner.

• Strong influencing and negotiation skills.

• Excellent written and oral communication skills.

• Strong interpersonal skills, including ability to communicate with individuals and groups at all levels. Experience establishing relationships with other functions within the company.

• Strong decision making and analysis skills.

• Demonstrated conflict and change management skills.

• Strategic Thinking – ability to view bigger picture and translate complex issues into solution-based answers that drive real and sustainable change.

• Proven hands-on experience with quality risk management methodologies

• Strong computer skills with Quality Systems.

• Sense of Urgency - ability to lead and deliver on multiple projects in a timely manner.

• Teamwork and Collaboration – ability to lead, manage and participate on teams with shared responsibility for decisions and results.

• Confidentiality – ability to maintain confidentiality as appropriate.

• Systems Thinker – understanding how process / actions interact and influence other areas within a whole

Required Years of Related Experience:

• Requires at least 15 years of experience with 5 plus years’ experience and demonstrated leadership in a quality function working on complex and significant compliance topics.

• Minimum 5 years of proven people leader experience

• Must have comprehensive knowledge of GxP, GMP, cGMP and IT compliance regulations and guidelines, with expert knowledge on US and EMEA Regulations

• Requires knowledge of latest auditing, investigation, and remediation techniques as well as leadership experience with inspections.

• Demonstrated effective influencing, interpersonal, written, and verbal communications skills as well as a proven track record of sustaining compliance in complex organizations.

• Regulatory Authority experience is desirable

• Experience with Regulatory Authorities is a significant asset

Required Knowledge, Skills and Abilities:

• Strong Quality and Compliance background with a deep understanding of Global GxP, GMP, cGMP requirements and the systems used to deploy them.

• Experience in the identification and management of risks, including the development of risk-based remediation strategies and reporting risks/status in a concise manner.

• Strong influencing and negotiation skills.

• Excellent written and oral communication skills.

• Strong interpersonal skills, including ability to communicate with individuals and groups at all levels. Experience establishing relationships with other functions within the company.

• Strong decision making and analysis skills.

• Demonstrated conflict and change management skills.

• Strategic Thinking – ability to view bigger picture and translate complex issues into solution-based answers that drive real and sustainable change.

• Proven hands-on experience with quality risk management methodologies

• Strong computer skills with Quality Systems.

• Sense of Urgency - ability to lead and deliver on multiple projects in a timely manner.

• Teamwork and Collaboration – ability to lead, manage and participate on teams with shared responsibility for decisions and results.

• Confidentiality – ability to maintain confidentiality as appropriate.

• Systems Thinker – understanding how process / actions interact and influence other areas within a whole.

• Travel requirements: approximately 20-30% global travel will be required.

This position is located in the US or EU and can be based at any Innovative Medicine Supply Chain site.

The anticipated base pay range for this position is :

173,000 --- 299,000 USD Annual

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.