Dir, Technical Compliance Excellence

Johnson & Johnson • New Brunswick, PA

13h • Hybrid

About The Position

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.

Requirements

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Quality Systems, or a related scientific discipline.
• Minimum 15 years of pharmaceutical, biotechnology, cell therapy, combination-product, medical-device, engineering, validation, Quality, or technical-operations experience.
• Demonstrated technical depth in validation, qualification, Quality Risk Management, or a related technical compliance discipline.
• Experience interpreting global regulatory expectations and translating them into practical technical or compliance strategies.
• Experience supporting global regulatory inspections, complex remediation, new technologies, capital projects, technology transfers, or enterprise transformation.
• Demonstrated ability to work across multiple sites, platforms, functions, and geographies without direct authority.
• Experience developing frameworks, methodologies, technical guidance, training, or enterprise capability programs.
• Strong knowledge of ICH Q8, Q9(R1), Q10, and Q12 and relevant global validation, qualification, data integrity, and lifecycle expectations.
• Broad understanding of process validation, CPV, cleaning validation, commissioning and qualification, computerized systems, analytical methods, contamination control, and technical risk assessment.
• Ability to distinguish enterprise compliance strategy from local technical execution and process ownership.
• Strong scientific judgment, systems thinking, executive communication, facilitation, and influencing skills.
• Ability to integrate regulatory, technical, Quality, patient, product, supply, and business considerations into clear strategic guidance.

Nice To Haves

• Advanced degree preferred.

Responsibilities

• 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.
• 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.
• 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.
• Provide enterprise technical compliance interpretation and strategic guidance for validation and qualification topics where evolving expectations, novel technologies, inconsistent practices, or significant regulatory risk require a common approach.
• Interpret emerging expectations related to process validation, continued process verification, cleaning validation, commissioning and qualification, equipment qualification, computerized systems, analytical methods, data integrity, contamination control, and validation lifecycle management.
• Develop enterprise principles, methodologies, templates, and strategic guidance that enable consistent application across platforms and sites.
• Provide independent challenge on significant validation strategies, particularly for novel technologies, major remediation, technology transfers, new facilities, product launches, or complex regulatory commitments.
• Identify enterprise vulnerabilities, recurring inspection themes, and opportunities for harmonization or preventive action.
• Partner with Quality, Engineering, Manufacturing, MSAT, Digital, and technical functions to ensure guidance is practical, scalable, and suited for execution by accountable teams.
• Provide strategic technical compliance support for topics that require enterprise interpretation or a consistent network response; The Director convenes and integrates the right enterprise expertise and helps convert it into a usable compliance strategy.
• Partner with Quality Systems, Quality Operations, Manufacturing, MSAT, Engineering, Regulatory Affairs, Product Development, Supply Chain, Technical Operations, Digital, and platform compliance leaders.
• Convene the appropriate subject-matter experts to develop enterprise positions on complex technical compliance issues.
• Provide clear compliance insights, strategic options, and independent challenge to governance bodies and senior leaders.
• Promote transparency regarding assumptions, evidence, unresolved questions, implementation considerations, and residual risk.
• Support alignment of enterprise approaches without assuming the decision rights or operational accountabilities of partner functions.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Director