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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.
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 execution remain with the applicable Quality Management System owners and accountable business functions.
Validation and Qualification Compliance Strategy
- 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.
- The role does not own validation master plans, protocols, execution, approval, qualification activities, validation decisions, or ongoing lifecycle management. These responsibilities remain with the designated Quality, Engineering, Manufacturing, MSAT, Digital, and operational process owners.
Complex and Emerging Technical Compliance Topics
- 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.
Cross Functional Partnership and Governance Support
- 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.
Qualifications
Education
- Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Quality Systems, or a related scientific discipline.
- Advanced degree preferred.
Experience
- 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.
Technical and Leadership Knowledge
- 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.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$150,000.00 - $258,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
