Specialist, QA Clinical GCP Auditor

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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 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 aSpecialist 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.

• Bachelors 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:

-

The anticipated pay ranges for additional locations are:

Spain The anticipated base pay range for this position is EUR 43600.00 EUR 70150.00
France The anticipated base pay range for this position is EUR 44100.00 EUR 71070.00
Italy The anticipated base pay range for this position is EUR 39800.00 EUR 64055.00

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 locations 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.