Johnson & Johnson is inviting applications for the Specialist Quality Assurance Auditor – Innovative Medicine position. The role focuses on quality assurance audits, regulatory compliance, and inspection support. Candidates with a background in Pharmacy, Life Sciences, Medicine, or a related discipline and experience in pharmacovigilance can apply.
The job description emphasizes pharmacovigilance expertise, PV compliance, safety data review, and quality assurance auditing.
Job Details
| Particulars | Details |
|---|---|
| Company | Johnson & Johnson |
| Job Title | Specialist Quality Assurance Auditor – Innovative Medicine |
| Functional Area | Quality Assurance |
| Job Focus | Pharmacovigilance Auditing |
| Job Locations | Mumbai, India; Petaling Jaya, Malaysia; Shanghai and Beijing, China; Singapore; Tokyo, Japan; Taguig, Philippines |
| Work Mode | Fully Onsite |
| Employment Type | Full-time |
| Minimum PV Experience | 2 years |
| Application Deadline | October 28, 2026 |
| Job Requisition ID | R-093737 |
Position Overview
The Specialist Quality Assurance Auditor role involves planning, conducting, and reporting research and development quality assurance audits. The position supports compliance with internal standards, corporate policies, and applicable regulatory requirements across GxP and non-regulated areas.
For candidates with a pharmacovigilance background, the role requires knowledge of PV operations, safety reporting, risk management, and pharmacovigilance regulations.
Responsibilities
- Plan, conduct, and report routine R&D Quality Assurance audits.
- Support non-routine audits, including due diligence, for-cause, cross-functional, and service provider audits.
- Ensure audit plans, standard procedures, and diagnostic tools are correctly applied.
- Support regulatory inspections in assigned roles.
- Complete assigned training to maintain inspection readiness.
- Participate in projects and cross-functional teams.
- Meet project priorities, checkpoints, and timelines.
- Provide guidance to business partners on routine compliance matters.
- Support responses to compliance inquiries and seek advice on complex issues.
Eligibility and Qualifications
Candidates should meet the following requirements:
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related discipline.
- Minimum 2 years of pharmacovigilance experience in the pharmaceutical or biotechnology industry.
- Hands-on experience in PV operations, such as case processing, signal detection, risk management, or safety surveillance.
Preferred qualification:
- At least 2 years of Quality Assurance auditing experience, specifically in Pharmacovigilance or Good Pharmacovigilance Practices (GVP) audits, including internal, external, or vendor audits.
Experience auditing PV systems, processes, databases, and service providers is also preferred.
Required Skills and Knowledge
Candidates should have knowledge of:
- EU Good Pharmacovigilance Practices and health authority requirements in Asian countries.
- Individual Case Safety Report (ICSR) management.
- Aggregate safety reporting, including PSUR/PBRER and DSUR.
- Product risk management and risk minimization activities.
- Vendor oversight and pharmacovigilance compliance models.
- Safety data analysis and compliance reviews.
Additional skills include:
- Analytical thinking and attention to detail.
- Effective communication and stakeholder management.
- Ability to manage multiple audits and priorities.
- Integrity, professionalism, and objective judgment.
- Cross-functional collaboration across geographical regions.
- Quality Management Systems (QMS), compliance management, internal controls, problem-solving, and continuous improvement.
