Associate Director, Audit Process Lead

Johnson & Johnson Innovative Medicine•Horsham, PA

2d•$122,000 - $212,750•Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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.

Requirements

Business Process Management (BPM)
Business Requirements Analysis
Compliance Management
Cross-Functional Collaboration
Data Savvy
Fact-Based Decision Making
ISO 9001
Leverages Information
Mentorship
Organizing
Process Governance
Process Optimization
Quality Control (QC)
Quality Standards
Quality Validation
Stakeholder Engagement
Standard Operating Procedure (SOP)
Tactical Thinking
Technical Credibility

Responsibilities

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.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year