Pharmacovigilance QA Leader — Audits & Compliance

Biopharma Careers; Raritan (NJ); On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson is seeking a Pharmacovigilance Quality Assurance Manager to lead auditing and inspection activities within a GxP environment. You will drive audits, CAPA follow-up, and risk-based quality improvements in collaboration with cross-functional teams.

The role requires at least 6 years in a GxP regulated setting with 3 in pharmacovigilance auditing, plus strong project management and excellent communication skills. Travel up to 25% is expected; multiple country postings may exist.

Qualifications

• Minimum of 6 years of relevant work experience in a GxP regulated industry including 3 years in pharmacovigilance auditing.
• Strong project management experience.
• Strong verbal and written communication skills.
• Strong teamwork and analytical skills.
• Experience in leading complex pharmacovigilance audit types is preferred.
• Must be fluent in English.

Responsibilities

• Auditing: leads planning, conduct, and reporting of audits/inspections in GxP/non-regulated areas.
• Inspection support: may participate in regulatory inspections in a leadership role.
• Training & development: identifies training needs and provides coaching to auditors.
• People management: supervises junior auditors/contractors; deputizes for Team Lead.
• Project management: leads initiatives and drives projects to completion.
• Expertise: shares regulatory knowledge and provides consultation on quality and compliance processes.

Skills

Project management

Verbal communication

Written communication

Teamwork

Analytical skills

Auditing (pharmacovigilance)

Education

Bachelor’s degree

Job description

Johnson & Johnson is seeking a Pharmacovigilance Quality Assurance Manager to lead auditing and inspection activities within a GxP environment. You will drive audits, CAPA follow-up, and risk-based quality improvements in collaboration with cross-functional teams.

The role requires at least 6 years in a GxP regulated setting with 3 in pharmacovigilance auditing, plus strong project management and excellent communication skills. Travel up to 25% is expected; multiple country postings may exist.