Associate Director – Business Engagement

Johnson & Johnson

. Establish effective business relationships with key stakeholders within 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

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Quality Assurance and Regulatory Compliance within the Pharmaceutical and Medical Device industries, with a strong focus on GxP requirements, audit execution, and process automation. Proficient in leveraging data analytics tools for compliance insights and real-time reporting.

Highest-signal resume keywords

Quality Assurance & Regulatory ComplianceGxP Audit ExecutionData Analytics Tools ProficiencyProcess Automation & Digital InnovationStrong Communication & Relationship Development

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

GxP AuditsRisk-Based Audit StrategiesProcess RemediationRegulatory Filing/Approval ProcessesAudit PlanningAudit ReportingData AnalyticsCompliance MetricsAudit Procedure ImprovementsRegulatory Compliance Expertise

Soft Skills

Problem-SolvingNegotiatingInfluencingInterpersonal SkillsDecision-Making

Tools & Technologies

AI-Enabled ToolsData Analytics PlatformsReal-Time Reporting DashboardsThoughtSpotSpotfire

Certifications & Qualifications

ISO Certified Lead AuditorASQ Certified Auditor

Industry Keywords

Pharmaceutical IndustryMedical Device IndustryOTC Drug IndustryGlobal cGMP RequirementsInnovative Medicines

About the role

Key responsibilities & impact

Establish effective business relationships with key stakeholders within 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 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, including audit records
Partner with Innovative Medicines EQ to drive audit execution, remove barriers and maintain alignment with enterprise audit commitments and governance standards
Design, develop and continuously improve Pre-Audit Intelligence Packages using enterprise quality systems and AI-enabled tools
Execute ERC site risk profiles for internal and external sites
Conduct quarterly audit data trend analysis and provide audit program performance metrics for compliance reviews and stakeholder reporting
Assist in formulating and implementing ERC audit procedure improvements
Monitor regulatory changes and communicate new requirements to the organization
Provide regulatory compliance subject matter expertise for acquisition and divestiture due diligence, new product initiatives, supplier/EM audit refusal and risk assessment processes
Complete Innovative Medicine Pharmacovigilance System Master File contributions for ERC audits as required
Support health authority and internal audits of the audit program as a subject matter expert
Develop and maintain real-time reporting dashboards and support audit management system data integration
Evaluate and implement artificial intelligence solutions for compliance analysis, pre-audit intelligence and audit program performance visibility
Lead process automation opportunities 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
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 outcomes concisely
Strong problem-solving, negotiating, influencing and relationship-development skills
Excellent written and oral communication and financial acumen
Strong decision-making, analysis and interpersonal skills, including communication with individuals and groups at all levels
Demonstrated ability to leverage data analytics tools and platforms for compliance insights, real-time reporting dashboards and audit program performance metrics
Demonstrated capability to drive digital process innovation and automation, including adopting artificial intelligence tools in a compliance or audit context
ISO Certified Lead Auditor or ASQ Certified Auditor preferred
Working knowledge of data analytics tools such as Spotfire preferred
Proficiency with ThoughtSpot, Spotfire and/or similar data analytics and visualization platforms preferred
Experience with AI-enabled tools such as Microsoft Copilot or CORA preferred
Ability to travel up to 20% domestically and internationally

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
Up to 20% domestic and international travel opportunity/coverage
Inclusive interview accommodation support