At a Glance
- Tasks: Lead the R&D Quality audit process and drive continuous improvement.
- Company: Join a global leader in pharmaceuticals with a commitment to innovation.
- Benefits: Competitive salary, annual bonus, generous leave policies, and wellness programmes.
- Other info: Dynamic role with opportunities for professional growth and cross-functional collaboration.
- Why this job: Make a real impact on patient outcomes while shaping audit processes.
- Qualifications: 8+ years in pharma or healthcare, with strong audit experience.
The predicted salary is between 96000 - 165025 £ per year.
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.
Location: 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.
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 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 appropriately.
- Excellent interpersonal, oral, and written communication skills to effectively influence cross‑functionally and engage externally with 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).
- 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.
Associate Director, Audit Process Lead employer: Johnson & Johnson Innovative Medicine
As an Associate Director, Audit Process Lead at our company, you will be part of a dynamic and innovative team dedicated to enhancing the R&D Quality audit process. We pride ourselves on fostering a collaborative work culture that values continuous improvement and employee growth, offering comprehensive benefits including generous parental leave, well-being programmes, and opportunities for professional development. Located in Beerse, Antwerp, Belgium, you will enjoy a vibrant community with access to diverse cultural experiences while contributing to meaningful patient outcomes.
Contact Details:
Johnson & Johnson Innovative Medicine Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Audit Process Lead
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend relevant events, and connect with people on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its audit processes. Understand their values and how they align with your experience. This will help you tailor your responses and show that you're genuinely interested in the role.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online platforms to get comfortable with common questions. The more you practice, the more confident you'll feel when it’s time to shine.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can go a long way in leaving a positive impression. Plus, it shows your enthusiasm for the position and keeps you on their radar.
We think you need these skills to ace Associate Director, Audit Process Lead
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in audit processes and compliance. We want to see how your skills align with the role of Associate Director, Audit Process Lead, so don’t hold back on showcasing your relevant achievements!
Showcase Your Strategic Thinking:In your written application, emphasise your ability to think strategically about audit processes. Share examples of how you've driven continuous improvement or implemented innovative solutions in past roles. This will help us see your potential impact on our team.
Be Clear and Concise:When writing your application, keep it clear and to the point. Use bullet points where possible to make your key achievements stand out. We appreciate a well-structured application that’s easy to read and highlights your strengths effectively.
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super straightforward – just follow the prompts and you’ll be good to go!
How to prepare for a job interview at Johnson & Johnson Innovative Medicine
✨Know Your Audit Processes
Make sure you have a solid understanding of the audit processes relevant to the role. Brush up on GxP environments and be ready to discuss how you've driven process improvements in your previous roles. This will show that you're not just familiar with the basics, but that you can bring valuable insights to the table.
✨Showcase Your Strategic Thinking
Prepare examples that highlight your ability to think strategically. Discuss how you've set audit strategies or roadmaps in the past, and how those initiatives led to measurable improvements. This will demonstrate your capability to elevate multidisciplinary practices and drive efficiency.
✨Emphasise Change Management Skills
Since change management is a key part of this role, come prepared with specific instances where you've successfully led change initiatives. Talk about how you communicated changes to stakeholders and ensured smooth transitions. This will illustrate your leadership and communication skills.
✨Engage with Data-Driven Insights
Be ready to discuss how you've used performance metrics and KPIs to drive enhancements in audit processes. Bring examples of how data has informed your decisions and led to better outcomes. This will show that you're not only data-savvy but also capable of leveraging insights for continuous improvement.
