Specialist Quality Assurance Auditor – Innovative Medicine

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 .

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.

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:

Main responsibilities will include but are not limited to:

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:

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