Specialist, QA Clinical GCP Auditor

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.
• 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.
• 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.
• 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