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Job Description:

The Associate Director, Audit Process Lead, will be the global, cross-domain Audit Business Process Owner (BPO) for R&D Quality (RDQ), with end-to-end accountability for the RDQ audit process across people, process, and technology. This role will set the strategic direction for the audit process, lead continuous improvement efforts, and ensure the process remains efficient, effective, compliant, and aligned with evolving regulatory expectations and industry leading practices.

This role will also expand and strengthen RDQ’s partnership with other audit-related functions within J&J, as well as external organizations, to establish a sustainable approach to innovation and audit process modernization.

• 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 our business partners and supporting better patient outcomes.

• Establish and monitor meaningful process performance data (e.g., 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.

Required Skills

• Bachelor’s degree in a scientific, medical, technical, or related discipline.
• A 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 multi-disciplinary practices, driving process improvement, leveraging efficiency & lean principles, and executing 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 an ability to balance priorities across multi-workstream initiatives, resolve roadblocks, and escalate appropriately.
• Excellent interpersonal, oral, and written communication skills to effectively influence cross-functionally and engage externally to our organization and J&J, to ensure leading practices are being adopted.
• Proficiency in English (written and verbal).
• Availability for limited travel (10% potentially, driven by business need).

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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The anticipated base pay range for this position is :

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