Associate Director – Business Engagement

Johnson & Johnson

. Build and maintain mutually beneficial relationships with J&J business partners aligned to the relevant business segment .

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 strategy development, and digital process innovation. Proficient in leveraging data analytics for compliance insights and performance metrics.

Highest-signal resume keywords

Quality Assurance & Regulatory ComplianceGxP Audit ExperienceData Analytics Tools ProficiencyDigital Process InnovationStakeholder Relationship Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GxP RequirementsAudit Strategy DevelopmentRisk-Based Audit PlanningRegulatory Filing ProcessesProcess RemediationCompliance Risk AssessmentAudit Performance MetricsContinuous ImprovementFinancial AcumenProduct/Process Development Principles

Soft Skills

Problem-SolvingNegotiatingInfluencingDecision-MakingInterpersonal Communication

Tools & Technologies

Data Analytics PlatformsReal-Time Reporting DashboardsAI ToolsAudit Management SystemsSpotfireThoughtSpotMicrosoft CopilotCORA

Certifications & Qualifications

ISO Certified Lead AuditorASQ Certified Auditor

Industry Keywords

Pharmaceutical IndustryMedical Device IndustryOTC Drug IndustryCGMP CompliancePharmacovigilance

About the role

Key responsibilities & impact

Build and maintain mutually beneficial relationships with J&J business partners aligned to the relevant business segment
Collect stakeholder feedback and business insights across supply chain and ERC areas
Enhance ERC (JJIA) knowledge of products, technology, and GxP services
Ensure ERC (JJIA) audit programs remain current
Develop fit-for-purpose audit strategies using stakeholder insights and regulatory requirements
Drive continuous improvement of the ERC (JJIA) audit program and auditor strategies
Standardize audit support activities and improve audit preparation through risk-based scheduling, resourcing, and pre-audit planning
Provide a holistic view of potential compliance risks across the J&J supply chain
Lead digital enablement of the ERC (JJIA) audit program through data analytics, visualization, automation, and AI solutions
Manage enterprise audit system records and annual audit schedules
Serve as subject matter expert and system champion for next-generation quality platforms
Establish stakeholder relationships and translate business insights 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
Develop Pre-Audit Intelligence Packages and execute risk profiles for internal and external sites
Conduct quarterly audit data trend analysis and report audit program performance metrics
Improve audit procedures for ERC (JJIA) auditors
Monitor regulatory changes and communicate new requirements
Provide regulatory compliance expertise for acquisitions, divestitures, new product initiatives, supplier/EM audit refusal, and risk assessment processes
Support pharmacovigilance system master file contributions and health authority/internal audits
Develop real-time reporting dashboards and support audit management system data integration
Identify and lead process automation opportunities across the end-to-end audit lifecycle

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 all segments of the business, product types and regions
Experience performing GxP audits, including development of risk-based audit strategies, audit planning, conducting audits and reporting audit outcomes
Strong problem-solving, negotiating, influencing, relationship-development, decision-making, analysis, interpersonal, written and oral communication skills
Financial acumen
Ability to communicate with individuals and groups at all levels
Demonstrated ability to leverage data analytics tools and platforms to develop compliance insights, real-time reporting dashboards, and audit program performance metrics
Demonstrated capability to drive digital process innovation and automation, including identification and adoption of artificial intelligence tools in a compliance or audit context
Preferred: Experience working in Medical Device/Pharmaceutical Industry
Preferred: ISO Certified Lead Auditor or ASQ Certified Auditor
Preferred: Working knowledge of data analytics tools such as Spotfire
Preferred: Proficiency in ThoughtSpot, Spotfire, or similar platforms; experience with AI-enabled tools such as Microsoft Copilot or CORA

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