Senior QA Auditor (Hybrid) – GCP & Regulatory Insight

Johnson & Johnson Co.; Spring House (PA); Hybride; USD 94 000 - 152 000; Plein temps

Avantages offerts par ce poste

Vacation time

Paid holidays

Parental Leave

Résumé du poste

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization across multiple sites in NJ, PA, and CA. This hybrid role requires reporting to a listed site 3x per week, with responsibilities spanning planning, conducting, and reporting GCP QA audits to ensure compliance and quality across programs.

The ideal candidate has 5+ years of auditing/clinical operations experience, deep knowledge of GCP and regulatory guidelines, and strong data

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.

Responsabilités

• Independently leads planning, conduct and reporting of GCP QA routine audits and supports non-routine audits.
• Ensures audit procedures, tools, and plans are applied in activities.
• Analyzes data and identifies patterns and trends in data sets.
• Ensures timely review and delivery of CAPAs from audits.
• Presents information clearly in reports and presentations.
• Provides GCP Audit strategy support, especially on risk-based auditing (Audit plans).
• Supports regulatory inspections in various roles.
• Completes required training to ensure inspection readiness.
• May assist in training material preparation.
• Participates in projects or teams as assigned.
• Meets priorities, checkpoints, and timelines for all work.

Connaissances

Auditing experience

GCP knowledge

Regulatory knowledge

Clinical operations understanding

Data analytics

Project management

Communication skills

Formation

Bachelor's degree

Description du poste

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization across multiple sites in NJ, PA, and CA. This hybrid role requires reporting to a listed site 3x per week, with responsibilities spanning planning, conducting, and reporting GCP QA audits to ensure compliance and quality across programs.

The ideal candidate has 5+ years of auditing/clinical operations experience, deep knowledge of GCP and regulatory guidelines, and strong data