Associate Director Business Engagement - Audit Program

About the role

Johnson & Johnson is recruiting an Associate Director Business Engagement for its Legal & Compliance function, Enterprise Compliance (ERC/JJIA). The role builds and maintains relationships with J&J business partners and collects stakeholder feedback to keep the ERC audit program current, fit for purpose and continuously improving. It can be performed at any US or EMEA J&J location, with postings in several countries.

Key responsibilities

• Build business relationships with key supply chain stakeholders and turn their insights into audit program strategies; act as the main liaison between the ERC audit team and quality and compliance stakeholders.
• Maintain the annual Innovative Medicines and External Manufacturer audit schedule and audit records, and partner with EQ to drive audit execution.
• Lead the design and improvement of pre-audit intelligence packages using enterprise quality systems and AI-enabled tools, run site risk profiles and quarterly trend analyses, and report audit performance metrics.
• Help improve ERC audit procedures and stay up to date with regulatory changes, acting as a subject matter expert for compliance due diligence, new products and supplier audits.
• Drive digital enablement: real-time dashboards, integration of audit management system data, AI solutions and process automation across the audit lifecycle.
• Manage enterprise audit system records, annual audit schedules and serve as a system champion for next-generation quality platforms.

Required profile

• Bachelor's degree (BS/BA) or equivalent 4-year degree, preferably in science, engineering, organizational management or a related field.
• Minimum 8 years of experience in a QA and regulatory compliance role in pharmaceutical, medical device and/or OTC drug industry.
• Deep understanding of global cGMP requirements and systems, and of product and process development and regulatory filing/approval processes.
• Experience performing GxP audits, including risk-based audit strategies, planning, execution and reporting.
• Preferred: ISO Certified Lead Auditor or ASQ Certified Auditor.
• Up to 20% domestic and international travel may be required.

Required skills

• Experience leveraging data analytics tools to build compliance insights, dashboards and audit performance metrics.
• Preferred: proficiency in data analytics and visualization tools such as ThoughtSpot and Spotfire, and AI-enabled tools such as Microsoft Copilot and CORA.