Associate Director – Business Engagement

Johnson & Johnson

. Establish effective business relationships with key stakeholders across the J&J supply chain to define ERC (JJIA) audit strategies .

Posted 11/2/2026full-timeHorsham • Pennsylvania • United StatesSenior💰 $127,000 - $218,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality and Compliance within the Pharmaceutical and Medical Device industries, with a strong focus on GxP requirements, audit execution, and regulatory compliance. Proficient in leveraging data analytics and AI tools to enhance audit processes and drive digital innovation.

Highest-signal resume keywords

GxP Audit ExecutionRegulatory Compliance ExpertiseData Analytics Tools ProficiencyProcess Remediation ExperienceDigital Process Innovation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceRegulatory ComplianceGxP AuditsAudit PlanningRisk-Based Audit StrategiesProcess Development PrinciplesAudit Program Performance MetricsPre-Audit IntelligenceAudit Procedure ImprovementsRisk Assessments

Soft Skills

Problem-SolvingNegotiatingInfluencingDecision-MakingInterpersonal Communication

Tools & Technologies

AI-Enabled ToolsData Analytics PlatformsReal-Time Reporting DashboardsMicrosoft CopilotSpotfireThoughtSpotCORA

Certifications & Qualifications

ISO Certified Lead AuditorASQ Certified Auditor

Industry Keywords

Pharmaceutical IndustryMedical Device IndustryOTC Drug IndustryGlobal cGMP RequirementsAudit LifecycleCompliance AnalysisSupplier Audit Refusal

About the role

Key responsibilities & impact

Establish effective business relationships with key stakeholders across the J&J supply chain to define ERC (JJIA) audit strategies
Collect insights on products, technology, GxP services, acquisitions, and divestitures and translate them into actionable audit program strategies
Serve as primary liaison between the ERC audit team and Innovative Medicines quality and compliance stakeholders
Develop and maintain the annual Innovative Medicines and External Manufacturer audit schedule and audit records
Partner with Innovative Medicines EQ to drive audit execution, remove barriers, and maintain alignment with enterprise audit commitments and governance standards
Design and improve Pre-Audit Intelligence Packages using enterprise quality systems and AI-enabled tools
Execute ERC site risk profiles for internal and external sites and conduct quarterly audit data trend analysis
Provide audit program performance metrics for JJRC Compliance reviews and quarterly stakeholder reporting
Formulate and implement ERC audit procedure improvements
Monitor regulatory changes and assess proposed regulations and new organizational requirements
Provide regulatory compliance subject matter expertise for acquisition/divestiture due diligence, new product initiatives, supplier/EM audit refusal and risk assessments, PSMF contributions, and health authority/internal audits
Develop and maintain real-time reporting dashboards and support audit management system data integration
Evaluate and implement AI solutions for compliance analysis, pre-audit intelligence, and automated reporting
Lead process automation across the end-to-end audit lifecycle
Perform other work-related duties as assigned

Requirements

What you’ll need

A minimum of a Bachelor’s degree (BS/BA) or equivalent 4-year degree is required; preferably in science, engineering, organizational management, or another related field
A minimum of 8 years of experience in a QA & Regulatory Compliance role within a Pharmaceutical, Medical Device and/or OTC Drug Industry environment
Strong Quality and Compliance background with a deep understanding of Global cGMP requirements and the systems used to deploy them
Strong understanding and experience with process remediation
Strong understanding of product/process development principles, including regulatory filing/approval processes across business segments, product types, and regions
Experience performing GxP audits, including risk-based audit strategies, audit planning, conducting audits, and reporting audit outcomes
Ability to leverage data analytics tools and platforms to develop compliance insights, real-time reporting dashboards, and audit program performance metrics
Capability to drive digital process innovation and automation, including adoption of artificial intelligence tools in a compliance or audit context
Strong problem-solving, negotiating, influencing, relationship-development, decision-making, analysis, interpersonal, written, oral communication, and financial acumen skills
Preferred: Medical Device/Pharmaceutical industry experience; ISO Certified Lead Auditor or ASQ Certified Auditor; working knowledge of Spotfire, ThoughtSpot, similar analytics/visualization platforms, Microsoft Copilot, or CORA
May require up to 20% domestic and international travel

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees
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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Inclusive interview process and disability accommodations