Global PV QA Auditor — R&D Compliance

Johnson & Johnson Sdn. Bhd.; Selangor; On-site; MYR 90,000 - 130,000; Full time

Job summary

Johnson & Johnson Sdn. Bhd. seeks a Specialist Quality Assurance Auditor for Innovative Medicine to lead QA audits and support regulatory inspections. The role focuses on pharmacovigilance processes, risk management, and vendor oversight, ensuring compliance with global PV standards and QMS.

The successful candidate will have PV auditing experience, strong analytical skills, and the ability to work across regions in a fast-paced environment, driving quality across all phases.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related discipline.
• Minimum 2 years of experience in Pharmacovigilance (PV) within the pharmaceutical or biotech industry.
• 2+ years of QA auditing experience, specifically in Pharmacovigilance / GVP audits.

Responsibilities

• Lead R&D Quality QA routine audits and support non-routine audits.
• Ensure standard procedures, diagnostic tools, and audit plans are applied.
• Support regulatory inspections in various roles.
• Complete training requirements for inspection readiness.

Skills

Analytical thinking

Attention to detail

Communication skills

Cross-functional collaboration

Audit management

Integrity

Professionalism

Education

Bachelor’s degree in Life Sciences or related

Job description

Johnson & Johnson Sdn. Bhd. seeks a Specialist Quality Assurance Auditor for Innovative Medicine to lead QA audits and support regulatory inspections. The role focuses on pharmacovigilance processes, risk management, and vendor oversight, ensuring compliance with global PV standards and QMS.

The successful candidate will have PV auditing experience, strong analytical skills, and the ability to work across regions in a fast-paced environment, driving quality across all phases.