Specialist, QA Clinical GCP Auditor

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: Quality

Job Sub Function: Quality Assurance

Job Category: Professional

All Job Posting Locations: Beerse, Antwerp, Belgium, Duelmen, Germany, Issy-les-Moulineaux, France, Madrid - Lafinca, Milano, Italy, Warsaw, Masovian, Poland

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

In R&D Quality, we continue to invest in our talent, diversity, and expertise to make quality a business differentiator and competitive advantage. By working closely with our business partners, we help deliver what matters most to customers and patients. We apply innovative, risk-based audit approaches that provide meaningful insights to help proactively strengthen compliance, sustainability, and reliability across Johnson & Johnson Innovative Medicine.

This hybrid role can be located near a Johnson & Johnson office and offers the flexibility of the J&J Flex model.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Belgium, Spain, France, Italy, Poland, Germany - Requisition Number: R-091908

Switzerland - Requisition Number: R-092908

UK - Requisition Number: R-092914

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for a Specialist, QA Clinical GCP Auditor.

Purpose

Are you interested in helping strengthen quality and compliance across global clinical development programs while working with innovative therapies and cross-functional teams?

As a Specialist, QA Clinical GCP Auditor, you will contribute to quality oversight across clinical development activities by supporting and leading Good Clinical Practice (GCP) audit activities. The role helps ensure adherence to corporate policies, internal standards, and applicable regulatory requirements while supporting a risk-based quality approach across Johnson & Johnson Innovative Medicine.

We look forward to learning more about you!

You will be responsible for

In this role, responsibilities include planning, conducting, and reporting routine GCP QA audits and supporting non-routine audit activities. Audit activities may include Clinical Investigator Site audits, Trial and Program audits, External Service Provider audits, Process and System audits, and Local Operating Country audits.

Working closely with internal and external partners, the role supports adherence to corporate requirements and applicable regulations while contributing to quality oversight across the clinical development lifecycle.

The position also contributes to data analysis, audit strategy activities, inspection support, and continuous enhancement of risk-based auditing practices.

Additional responsibilities include:

• Leading routine GCP QA audits and supporting non-routine audits, including due diligence, for-cause, cross-functional, and complex audit activities

• Applying standard procedures, audit tools, and audit plans during audit execution

• Analyzing and interpreting data and identifying patterns and trends that support quality oversight activities

• Supporting timely review and follow-up of CAPAs and audit-related actions

• Preparing clear and concise audit reports and presenting information effectively both verbally and in writing

• Contributing to GCP audit planning activities, including risk-based audit approaches

• Supporting regulatory inspections in assigned support roles

• Maintaining training requirements to support inspection readiness

• Assisting with development of training materials, when requested

• Participating in projects and cross-functional teams as assigned

• Managing priorities, timelines, and project deliverables to support business objectives

• Supporting the application of digital tools, analytics, and AI-enabled approaches, where appropriate

Qualifications / Requirements

We are looking for someone who combines strong quality and compliance expertise with analytical thinking, collaboration, and a commitment to continuous learning.

• Bachelor's degree required

• Advanced degree in a scientific, medical, or related discipline is preferred

• Experience in Clinical Quality & Compliance, Clinical Operations, or another relevant R&D function is required

• Knowledge of the drug development process, applicable regulations, R&D practices, and scientific and quality terminology

• Knowledge of Good Clinical Practice (GCP) requirements and applicable regulations and guidelines, including FDA regulations, EU CTR, and ICH E6 R3

• Understanding of clinical trial risk management principles

• Knowledge of standard operating procedures, good documentation practices, and records management

• Experience using digital tools, business applications, and data analytics solutions

• Ability to analyze information and identify trends and opportunities

• Ability to plan, prioritize, and manage work effectively in a time-sensitive environment

• Strong written and verbal communication skills

• Ability to present information clearly to a variety of audiences

• Ability to collaborate effectively within cross-functional environments

• Fluent in English, both written and spoken

• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity

What we offer

We offer a collaborative environment where learning, innovation, and professional development are encouraged.

In this role, you will have the opportunity to work across global teams, contribute to meaningful quality initiatives, and support the development of innovative medicines that help improve patients' lives.

Additional role information

• Up to 30% domestic and/or international travel may be required

• Hybrid working model in alignment with J&J Flex

Our commitment to inclusion

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.

We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.

If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.

Thank you for considering a career with Johnson & Johnson.

#LI-Hybrid

Required Skills:

Preferred Skills: Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

The anticipated pay range for this position, in the primary posting location, is: €60 000,00 - €96 255,00

The anticipated pay ranges for additional locations are: [Spain] – The anticipated base pay range for this position is [EUR 43,600.00] – [EUR 70,150.00]​ [France] – The anticipated base pay range for this position is [EUR 44,100.00] – [EUR 71,070.00]​ [Italy] – The anticipated base pay range for this position is [EUR 39,800.00] – [EUR 64,055.00]​

Benefits:

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.