Director, Audit Strategy & Stakeholder Engagement

Johnson & Johnson Co.; Limerick; On-site; EUR 86,000 - 148,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson is recruiting an Associate Director, Business Engagement. This role can be performed at any US or EMEA location, focusing on building strategic relationships with business partners across supply chain and ERC to drive audit program excellence.

You will lead data analytics, standardize audit processes, and champion digital solutions to provide near-real-time insights, while ensuring compliance with global GxP requirements and regulatory standards.

Qualifications

• Minimum 8 years in QA & Regulatory Compliance in pharmaceutical/medical device environments.
• Strong knowledge of Global cGMP and regulatory filing processes across regions.
• Experience performing GxP audits and developing risk-based audit strategies.

Responsibilities

• Establish effective business relationships with key stakeholders to define audit strategies and serve as liaison between ERC audit team and Innovative Medicines quality and compliance stakeholders.
• Lead the annual audit schedule for Innovative Medicines and External Manufacturer (EM), coordinating with EQ to drive audit execution and governance.
• Design and improve Pre-Audit Intelligence Packages by integrating data from quality systems and AI tools to generate actionable insights.
• Assist in formulating ERC (JJIA) audit procedure improvements for auditors.
• Monitor regulatory changes and provide SME support for acquisitions, due diligence, and supplier audits.
• Drive digital enablement of the audit program by developing real-time dashboards and AI-assisted reporting; champion automation across the lifecycle.
• Other duties as assigned.

Skills

QA & Regulatory Compliance

GxP compliance

Audit planning

Data analytics

AI compliance tools

Stakeholder management

Education

Bachelor's degree (BS/BA) or equivalent 4-year degree

Tools

Spotfire

ThoughtSpot

AI-enabled tools (Copilot, CORA)

Job description

Johnson & Johnson is recruiting an Associate Director, Business Engagement. This role can be performed at any US or EMEA location, focusing on building strategic relationships with business partners across supply chain and ERC to drive audit program excellence.

You will lead data analytics, standardize audit processes, and champion digital solutions to provide near-real-time insights, while ensuring compliance with global GxP requirements and regulatory standards.