Pharmacovigilance QA Auditor Specialist

Scorpion Therapeutics; Horsham (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a Pharmacovigilance QA Auditor Specialist to lead PV internal and external audits, support regulatory inspections, and ensure GxP compliance across diverse areas. The role involves collaboration with business partners and travel up to 25% to domestic and international sites.

The position is based in Horsham, PA, with options aligning to Raritan, NJ or Titusville, NJ, and requires strong project management, data analysis, and communication skills

Qualifications

Responsibilities

• Plan, conduct, and report audits
• Collaborate with business partners on compliance inquiries
• Support audit preparations and may assist in training material development

Skills

Pharmacovigilance auditing

Regulatory inspections

Data analysis

Project management

Communication skills

Microsoft Office

Education

Bachelor’s degree in life sciences

Tools

Microsoft Office Suite

Job description

Role: Pharmacovigilance QA Auditor Specialist responsible for leading PV internal and external audits, supporting regulatory inspections, and ensuring compliance across GxP and non-regulated areas within Johnson & Johnson's Innovative Medicine division.

Responsibilities

• plan, conduct, and report audits
• collaborate with business partners on compliance inquiries
• support audit preparations and may assist in training material development

Requirements

• Bachelor’s degree (preferably in life, natural, or computer science)
• at least 4 years of relevant PV experience
• strong project management, data analysis, and communication skills
• proficiency with Microsoft Office

Preferred

• understanding of auditing processes and experience with various audit types

High-Value

• focus on pharmacovigilance, GxP compliance, internal/external audit leadership, regulatory inspections, and global collaboration

Work setup involves 25% domestic/international travel.

The position is based in Horsham, PA; Raritan, NJ; or Titusville, NJ.