Associate Director, Audit Process Lead

Job Description

The Associate Director, Audit Process Lead (Global Audit Business Process Owner) will oversee the R&D Quality audit process across people, process, and technology, setting strategic direction, driving continuous improvement, and ensuring compliance with evolving regulatory expectations.

Beerse, Antwerp, Belgium;
High Wycombe, Buckinghamshire, United Kingdom;
Horsham, Pennsylvania, United States of America;
Raritan, New Jersey, United States of America;
Spring House, Pennsylvania, United States of America

• Set the RDQ audit process strategy and roadmap, focused on continuous improvement to make the process simpler, more consistent, and more efficient while elevating value to business partners and supporting better patient outcomes.
• Establish and monitor meaningful process performance data (KPIs, KRIs, stakeholder feedback, audit outcomes, inspection learnings, non‑conformance trends) to identify and drive improvement opportunities.
• Explore and identify practical digital enablers that strengthen audit processes, data quality, and user experience, delivering realized value to the organization.

• Serve as the RDQ representative in cross‑organizational audit forums to share RDQ priorities, influence standards and ways of working, and ensure changes impacting the audit process are aligned with RDQ business needs.
• Maintain an active external and cross‑J&J perspective on audit trends, emerging expectations, and new ways of working to ensure the RDQ audit process continues to evolve with regulatory expectations and business changes.
• Build strong relationships with other J&J audit‑related functions and external organizations to identify leading practices and incorporate relevant learnings into the RDQ audit process.

• Lead change management for audit process updates to ensure RDQ and business partners have a clear understanding of the change and impact, enabling seamless transitions.
• Ensure audit process guidance, Knowledge Hub content, job aids, communications, and training materials are current, easy to access, and clear enough to support consistent execution across RDQ audit teams.
• Proactively seek feedback to identify auditor capability needs and set strategy to fill gaps with appropriate tools, training, and upskilling support.

• Lead annual cross‑domain audit planning and scheduling, with ongoing monitoring of schedule conformance KPIs.
• Serve as the central audit process SME for inspections, internal audits, and cross‑domain audit process questions that require end‑to‑end process knowledge and coordinated RDQ input.
• Support execution of RDQ internal audit program and ensure effective audit and inspection response processes, as needed.
• Oversee audit process‑related impact assessments, non‑conformance management, and critical issue resolution, ensuring appropriate SME input, timely follow‑through, and sustainable process fixes.
• Facilitate external audit response management, as needed, including effective resolution of issues.
• Serve as backup for auditors during periods of high workload or unforeseen circumstances to ensure business continuity.

• Bachelor’s degree in a scientific, medical, technical, or related discipline.
• Minimum of 8 years of experience in pharmaceutical, healthcare, or adjacent industries, ideally within GxP environments (e.g., GCP, GLP, GMP).
• Demonstrated experience conducting audits (internal or external), including planning, execution, reporting, and follow‑up.
• Ability to think strategically to elevate multidisciplinary practices, drive process improvement, leverage efficiency & lean principles, and execute change management.
• Ability to innovate by identifying gaps, exploring digital or alternative solutions, building the case for change, and leading implementation to deliver value.
• Strong capability in performance management, using data‑driven insights, metrics, KPIs to drive measurable enhancements.
• Strong project management capabilities, including the ability to balance priorities across multi‑workstream initiatives, resolve roadblocks, and escalate…