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About the Role

Johnson & Johnson is dedicated to improving global health through healthcare innovation. This role contributes to that mission by ensuring adherence to quality standards and regulatory compliance within R&D.

Responsibilities

Lead the planning, conduct, and reporting of R&D Quality QA routine audits and support non-routine audits of activities, data, internal facilities, and processes in GxP/non-regulated areas.
Ensure relevant standard procedures, diagnostic tools, and audit plans are understood and applied in audit activities.
Support regulatory inspections in various supporting roles.
Complete assigned training requirements in a timely manner to ensure inspection readiness.
Assist in the preparation of training material if requested.
Participate in projects or serve on teams as assigned by supervisor.
Meet priorities, checkpoints, and timelines for all aspects of work and projects.
Provide consultation to business partners on routine tasks with occasional supervision.
Cooperate with business partners on compliance inquiries and seek advice on non-routine and complex issues.

Requirements

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.
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 (PSUR/PBRER, DSUR), product risk management, and vendor oversight.
Experience auditing PV systems, processes, databases, and service providers is preferred.
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.

Skills

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

Location

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

Work Type

Full-time

Experience Level

Minimum 2 years of experience in Pharmacovigilance
2+ years of QA auditing experience

Education Level

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

About the Company

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.