Senior QA Auditor, Clinical Trials & GCP Compliance

Johnson & Johnson Co.; Horsham (PA); Hybrid; USD 94,000 - 152,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization with location options across Titusville, NJ; Raritan, NJ; Horsham, PA; Spring House, PA; Irvine, CA; or La Jolla, CA. This is a hybrid role requiring 3 days on site per week at selected sites.

You will lead GCP QA audits, ensure compliance with regulatory requirements, and drive risk-based auditing strategies to support product development and patient safety.

Qualifications

• A minimum of 5 years of related work experience in auditing, clinical operations, or other key related area.
• Knowledge of the drug development process, applicable regulations, R&D practices, and scientific and quality terminology.
• Knowledge of Good Clinical Practices (GCP) and applicable regulations/guidelines (e.g. FDA regulations, EU CTR, ICH E6 R2).
• Experience conducting Clinical Quality Assurance audits or assessments of clinical investigator sites, studies, or systems.
• Understanding of fundamentals of clinical trial risk management.
• Broad knowledge of management of standard operating procedures, good documentation practices, and records management.
• Digital literacy & Analytics - Experience using standard applications/systems & data analytics tools.
• Ability to plan and prioritize work in an efficient manner, and to work well under time constraints.
• Flexibility to respond to changing business needs.

Responsibilities

• Independently leads the planning, conduct and reporting of GCP QA routine audits and supports non-routine GCP audits including Clinical Investigator Site audits, Trial/Program audits, External Service Provider audits, Process/System audits, Local Operating Country audits, to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.
• Ensures the relevant standard procedures, audit tools, and audit plans are fully understood and applied in audit activities.
• Analyzes, interprets data and identifies patterns and trends in data sets.
• Ensures timely and appropriate review & delivery of CAPAs and actions arising from audits.
• Presents information logically and concisely, both verbally and in writing, including writing reports with clarity
• Provides GCP Audit strategy support, especially on QA risk-based auditing approach (Audit plans)
• Supports regulatory inspections in various supporting roles.
• Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.
• May assist in the preparation of training material if requested.
• Participates in projects or serves on teams, as assigned by supervisor.
• Meets priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress.

Skills

GCP knowledge

Auditing experience

Data analytics

English communication

Education

Bachelor's degree

Tools

Audit tools

Job description

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization with location options across Titusville, NJ; Raritan, NJ; Horsham, PA; Spring House, PA; Irvine, CA; or La Jolla, CA. This is a hybrid role requiring 3 days on site per week at selected sites.

You will lead GCP QA audits, ensure compliance with regulatory requirements, and drive risk-based auditing strategies to support product development and patient safety.