Specialist Quality Assurance Auditor – Innovative Medicine

8275-Johnson & Johnson Sdn. Bhd. Legal Entity; Malaysia; On-site; MYR 100,000 - 180,000; Full time

Job summary

Johnson & Johnson Sdn. Bhd. Legal Entity in Malaysia seeks a Pharmacovigilance Auditor to lead PV audits, ensure GxP compliance, and support regulatory inspections. The role requires a life sciences degree and PV/GVP experience, with strong analytical and cross-functional collaboration skills.

The successful candidate will work within a global quality team, handle complex audits, and contribute to risk management and safety surveillance activities across PV systems.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related discipline.
• Proven PV operations experience or related PV roles.
• 2+ years QA auditing experience in PV/GVP audits.

Responsibilities

• Lead planning, conduct and reporting of PV audits in GxP/non-regulated areas.
• Support regulatory inspections in various roles.
• Complete assigned training to ensure inspection readiness.
• Participate in projects and meet timelines.
• Provide consultation to business partners on routine tasks.

Skills

Data Analysis

Detail-Oriented

Quality Control

Cross-functional

Compliance

Education

Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related discipline

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

Professional

All Job Posting Locations

• Beijing, China
• Chiyoda, Tokyo, Japan
• Mumbai, Maharashtra, India
• Petaling Jaya, Selangor, Malaysia
• Shanghai, China
• Singapore, Singapore
• Taguig, National Capital Region (Manila), Philippines

Job Description

• Auditing: Leads the planning, conduct and reporting of R&D Quality QA routine audits and supports non-routine audits of activities, data, internal facilities and processes in GxP/non-regulated areas to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.
• Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.
• Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
• Inspection Support: Supports regulatory inspections in various supporting roles.
• Training & Development: Completes assigned training requirements in a timely manner to ensure inspection readiness at all times. May assist in the preparation of training material if requested.
• People Management: N/A
• Project Management: Participates in projects or serves on teams, as assigned by supervisor. Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress.
• Subject Matter Expert / Point of Contact: Provides consultation to business partners on routine tasks with occasional supervision. Cooperates with business partners when contacted for compliance inquiries and seeks advice on non-routine and more complex issues to ensure a departmental unified position.

Job Requirements (Pharmacovigilance Auditor Focus) Education & Experience

• 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.
• Proven hands‑on experience in PV operations (e.g., case processing, signal detection, risk management, safety surveillance) or other PV-related roles.
• 2+ years of QA auditing experience, specifically in Pharmacovigilance / GVP audits (internal, external, or vendor audits) is preferred.

Pharmacovigilance Expertise (Critical Requirement)

• Knowledge of Pharmacovigilance regulations and guidelines, including: EU Good Pharmacovigilance Practices and Health Authority requirements in Asian countries.
• Understanding of end-to-end PV processes, including: Individual Case Safety Report management.
• Aggregate reporting (i.e. PSUR/PBRER, DSUR).
• Product risk management and implementation of risk minimization activities.
• Vendor oversight and PV compliance models.
• Experience auditing PV systems, processes, databases, and service providers is preferred.

Skills & Competencies

• Strong analytical thinking and attention to detail, particularly in safety data and compliance reviews.
• Excellent communication skills, with the ability to influence and challenge stakeholders constructively.
• Ability to manage multiple audits and priorities in a fast-paced, global environment.
• High level of integrity, professionalism, and objective judgment in sensitive or high-impact audit situations.
• Proven ability to work cross-functionally and across geographies.

Required Skills

• Business Alignment
• Business Behavior
• Coaching
• Compliance Management
• Continuous Improvement
• Data Analysis
• Detail-Oriented
• Goal Attainment
• Human-Centered Design
• Internal Controls
• Issue Escalation
• Problem Solving
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards

Preferred Skills

• Business Alignment
• Business Behavior
• Coaching
• Compliance Management
• Continuous Improvement
• Data Analysis
• Detail-Oriented
• Goal Attainment
• Human-Centered Design
• Internal Controls
• Issue Escalation
• Problem Solving
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.