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

Johnson & Johnson Innovative Medicine•Horsham, PA

About The Position

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. 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). 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.

Requirements

BS degree required. Masters or advanced degree in a scientific field (Life Sciences, Pharmacy, Engineering) desirable.
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 experience building Quality Risk Management and Regulatory Intelligence programs.
Requires knowledge of 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.
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.

Nice To Haves

Regulatory Authority experience is desirable.
Experience with Regulatory Authorities is a significant asset.
Industry experience supporting remediation activities, including developing compliance and sustainable solutions to audit/inspection findings, QMS trends, etc.
Knowledge and experience with ISO 31000 Quality Risk Management, ISO 9001 Quality Management Systems, ICH Q9, data analytics and reporting.
Global Experience
Process Excellence experience

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 the industry, which will inform strategic initiatives and ensure that the organization remains aligned with best practices and competitive standards.
Establishing, implementing, and maintaining a quality risk management program in compliance with ICH Q9 and other applicable GxP Risk Management requirements.
Monitoring and ensuring current and new Quality Risk Management regulations, guidelines and industry trends are appropriately implemented into the Quality System (QS).
Collaborate with key stakeholders to develop integrated risk-based approaches to collect, standardize, analyze as well as maintain risk-assessments and plans.
Designing and reporting quality risk metrics, risk review results and risk mitigation actions.
Contribute business cycles and portfolio management to ensure appropriate funding is available for risk mitigation activities.
Coordinating risk management activities and overseeing the QRM system to enable timely identification and communication of quality and compliance risks, and appropriate mitigation and risk reduction actions.
Assist with the identification of potential systemic gaps and develop and propose remediation plans for global and / or cross-divisional implementation.
Lead the established strategy and execution of the Regulatory Intelligence Program.
Responsible for providing strategic direction for communication with Regulatory Authorities post inspection, including the Regulatory Compliance review and input to inspection observation responses prior to submission and the oversight of inspection commitments ensuring documented evidence.
Provide independent and strategic direction and advice for communication with Regulatory Authorities related to compliance issues (inspection and non-inspection related).
Provide expert strategy and advice to business partners related to regulatory requirements.
Responsible for external influencing, working with the regulators, defining key strategies for influencing with global Health Authorities.
Oversee ongoing monitoring (mining) of external industry and internal J&J inspection outcomes and trends, ensuring the information is proactively shared within Q&C and Business partners.
Partner with site leadership, Subject Matter Experts, Process Owners, Johnson & Johnson Regulatory Compliance, and key stakeholders, etc. to develop and oversee program management activities linked to sites under risk management programs; with the key objective to ensure sustainable compliant solutions are identified and implemented to support risk management lifecycle.
Oversee supporting the development and management of the IM Supply Chain Compliance Risk Management Programs (e.g., SD-CAP, Proactive Monitoring, CAP, etc.).
Will work to develop documented compliance remediation plans that include measurable time-based actions/deliverables.
Will oversee the administration of Project Management processes across assigned compliance remediation initiatives.
Will partner to facilitate deployment of assigned compliance improvement initiatives/programs. This includes tracking remediation initiative performance, facilitating actions to address remediation risks, coordination of independent confirmation/verification assessments and preparing consolidated / actionable views of risks associated with remediation initiatives.
Collect and review Compliance Remediation metrics / data for JSCQ management, including support for regular and AdHoc JSCQ Compliance reviews.
Strong leader with the ability to establish clear strategy that can inspire others to deliver and influence to drive change across the organization.
Build and lead a strong team, distributed across multiple locations.
Actively encourage the development of the team while continuously raising the bar on performance, technical depth, product management results, and people management as new talent is hired.
Define and build metrics and KPIs to continuously monitor analyze outcomes.