Pharmacovigilance QA Auditor Specialist

Scorpion Therapeutics; Raritan (NJ); On-site; USD 85,000 - 140,000; Full time

Job summary

Pharmacovigilance QA Auditor Specialist at Johnson & Johnson's Innovative Medicine division oversees PV internal and external audits to ensure compliance. You will lead audit planning, assess data, facilities and processes in GxP and non-regulated areas, and support regulatory inspections.

You will provide compliance consultation to business partners, participate in projects, prepare audit reports, and help develop training materials to strengthen pharmacovigilance quality programs globally.

Qualifications

• Bachelor's degree in life, natural, or computer science.
• Minimum 4 years' PV experience.
• Strong project management, data analysis, communication, and collaboration skills.
• Proficiency with Microsoft Office.

Responsibilities

• Oversee PV internal and external audits.
• Lead audit planning and reporting.
• Assess data, facilities, and processes in GxP and non-regulated areas.
• Support regulatory inspections and provide compliance consultation.
• Participate in projects and assist in training material development.

Skills

Project management

Data analysis

Communication

Collaboration

PV experience

Education

Bachelor's degree in life/natural/computer science

Tools

Microsoft Office

Job description

Role

Pharmacovigilance QA Auditor Specialist responsible for overseeing PV internal and external audits to ensure compliance within Johnson & Johnson's Innovative Medicine division. Main objectives include leading audit planning, conducting assessments of data, facilities, and processes in GxP and non-regulated areas, supporting regulatory inspections, and providing compliance consultation to business partners. Responsibilities encompass project participation, audit reporting, and assisting in training material development.

Requirements

• Bachelor's degree in life, natural, or computer science; minimum 4 years' PV experience; strong project management, data analysis, communication, and collaboration skills; proficiency with Microsoft Office.

Preferred

• broader audit landscape understanding and varied audit experience.

Travel

approximately 25% domestically and internationally.

High-Value

PV compliance, GxP auditing, regulatory inspections, cross-functional collaboration, focus on quality assurance in pharmacovigilance processes, supporting global audit and compliance initiatives.