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-timeZug • SwitzerlandSeniorWebsite

Core Competencies

Role fit

Core Competencies

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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 improvement. Proficient in leveraging data analytics and AI tools to enhance audit strategies and compliance insights.

Highest-signal resume keywords

Quality Assurance & Regulatory ComplianceGxP Audit ExecutionData Analytics & VisualizationProcess RemediationISO Certified Lead Auditor

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GxP AuditsRisk-Based Audit StrategiesRegulatory Filing ProcessesAudit Program Performance MetricsProcess Development PrinciplesAudit PlanningAudit ReportingCompliance Insights DevelopmentDigital Process InnovationAI Tools Adoption

Soft Skills

Problem-SolvingNegotiatingInfluencingRelationship DevelopmentCommunication Skills

Tools & Technologies

Data Analytics ToolsReal-Time Reporting DashboardsAudit Management SystemsAI-Enabled ToolsSpotfireThoughtSpotMicrosoft Copilot

Certifications & Qualifications

ISO Certified Lead AuditorASQ Certified Auditor

Industry Keywords

Pharmaceutical IndustryMedical Device IndustryOTC Drug IndustryGlobal cGMP RequirementsRegulatory ComplianceAudit Lifecycle StandardizationStakeholder EngagementInnovative MedicinesExternal Manufacturer AuditsHealth Authority Audits

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 actionable audit program strategies
Serve as primary liaison between the ERC audit team and Innovative Medicines quality and compliance stakeholders
Lead development and maintenance of 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
Lead design and continuous improvement of 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 reporting for JJRC Compliance reviews and quarterly stakeholder reporting
Formulate and implement ERC (JJIA) audit procedure improvements
Monitor regulatory changes and communicate new requirements to the organization
Provide regulatory compliance subject matter expertise for acquisition/divestiture due diligence, new product initiatives, and supplier/External Manufacturer audit refusal and risk assessments
Complete Innovative Medicine Pharmacovigilance System Master File contributions for ERC audits and support health authority and internal audits as a subject matter expert
Drive digital enablement, real-time reporting dashboards, audit management system data integration, AI solutions, process automation, and end-to-end audit lifecycle standardization
Perform other work-related duties as assigned

Requirements

What you’ll need

Minimum of a Bachelor’s degree (BS/BA) or equivalent 4-year degree required
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 deep understanding of Global cGMP requirements and related systems
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
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
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 identification and adoption of AI 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 in data analytics and visualization tools such as ThoughtSpot, Spotfire, or similar platforms preferred
Experience with AI-enabled tools such as Microsoft Copilot or CORA preferred

Benefits

Comp & perks

Inclusive work environment
Equal employment opportunity
Interview process accommodations for applicants with disabilities
Up to 20% domestic and international travel may be required