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.
Job Function:
QualityJob Sub Function:
Business Process QualityJob Category:
ProfessionalAll Job Posting Locations:
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 AmericaJob Description:
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.
Main responsibilities will include, but are not limited to:Audit Strategy & Performance- 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).
Required Skills:
Audit Inspections, Data Insights, GxP Compliance, Performance Management (PM), PharmaceuticsPreferred Skills:
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
The anticipated base pay range for this position is:
€96’000.00 - €165’025.00Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
