Dir, Technical Compliance Excellence

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: Legal & Compliance Job Sub Function: Enterprise Compliance Job Category: People Leader All Job Posting Locations: Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America Job Description: Director, Technical Compliance Excellence Location: NJ/PA Reports To: VP, IMRC Travel: 10–25% Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Position Summary The Director, Technical Compliance Excellence is an enterprise compliance leader responsible for translating emerging and evolving regulatory expectations into practical, science- and risk-based, and globally consistent compliance approaches that can be deployed across the Innovative Medicine network. The role provides enterprise technical compliance expertise for complex or novel topics where the organization requires a common interpretation, methodology, framework, template, or strategic approach. The Director connects regulatory intelligence and inspection learning with the technical and operational expertise of Quality, Manufacturing, MSAT, Engineering, Regulatory Affairs, Product Development, Supply Chain, Digital, and Technical Operations. The role is intentionally focused on enterprise interpretation, technical compliance strategy, independent challenge, consistency, capability building, and organizational learning. It does not serve as the process owner for Quality Risk Management, validation, qualification, or other Quality Management System processes, and it does not replace technical capability within platforms, sites, or project teams. Mission Translate emerging regulatory expectations and complex technical compliance questions into clear, practical, and globally consistent enterprise approaches, enabling accountable functions to execute effectively while reducing fragmented interpretation, avoidable rework, inconsistent practices, and regulatory risk across the network. Role Focus Determine what emerging technical compliance expectations mean for the Innovative Medicine network. Define enterprise principles, methodologies, frameworks, templates, and strategic approaches where a common position is needed. Enable platforms, sites, and project teams to apply those approaches consistently without creating a centralized execution bottleneck. Provide independent technical compliance challenge for significant, novel, or enterprise-relevant risks. Build organizational capability and make expertise, expectations, and lessons accessible across the network. Key Responsibilities Emerging Regulatory Expectations and Enterprise Interpretation Leverage regulatory intelligence, Health Authority publications, enforcement trends, inspection findings, and internal learning provided through established enterprise channels. Assess potential technical compliance implications for products, processes, technologies, sites, platforms, and lifecycle stages. Translate relevant signals into clear enterprise compliance questions, applicability considerations, strategic options, and recommended approaches. Identify topics that require a common enterprise position rather than separate local interpretations. Engage the appropriate technical, Quality, Regulatory, and business experts to develop a science- and risk-based position. Escalate significant gaps, unresolved interpretations, or emerging risks through appropriate governance pathways. undefined Enterprise Technical Compliance Strategy and Methodologies Develop and maintain practical frameworks, methodologies, templates, decision principles, and guidance for complex or evolving technical compliance topics. Define what good looks like from a regulatory compliance perspective while enabling accountable functions to determine and execute the appropriate technical solution. Promote globally consistent approaches while allowing justified adaptation based on product, process, technology, platform, lifecycle stage, and local regulatory requirements. Provide strategic support for novel technologies, significant remediation, new product introductions, technology transfers, capital projects, and network changes when enterprise technical compliance interpretation is needed. Evaluate whether proposed approaches are scientifically sound, risk-based, aligned with current regulatory expectations, and defensible during inspection. Quality Risk Management Compliance Expertise Provide technical compliance expertise on the use of risk-based approaches for significant, novel, or emerging regulatory topics without owning the enterprise QRM process or routine risk-assessment execution. Develop fit-for-purpose risk-assessment approaches, templates, criteria, and decision considerations when existing tools do not adequately address a novel or complex regulatory concern. Challenge whether significant risk assessments appropriately consider regulatory expectations, scientific evidence, uncertainty, patient and product impact, lifecycle implications, and cross-network applicability. Support consistent use of risk-based principles in enterprise technical compliance strategies. Partner with Quality Management System and process owners to ensure technical compliance approaches align with established QRM governance and procedures. Build capability so sites and platforms can independently execute robust risk assessments using agreed methods and tools. Routine QRM process ownership, facilitation, risk acceptance, risk decisions, and