Specialist, QA Clinical GCP Auditor in High Wycombe

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.

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.

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.

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.

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.

You will be responsible for:

• Planning, conducting, and reporting routine GCP QA audits and supporting non-routine audit activities.
• Working closely with internal and external partners to support adherence to corporate requirements and applicable regulations.
• Contributing to data analysis, audit strategy activities, inspection support, and continuous enhancement of risk-based auditing practices.
• 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.
• 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.

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.