Senior Specialist Quality Assurance Auditor

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.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Bangkok, Bangkok, Thailand, Jakarta, Indonesia, Petaling Jaya, Selangor, Malaysia, Singapore, Singapore

Job Description:

Main responsibilities will include, but are not limited to:

Auditing

• Independently leads the planning, conduct, reporting of R&D Quality QA routine and non-routine audits/assessments/inspections of activities, data, internal facilities and processes in GxP 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.  Manages complex or business critical audits/issues in a supporting or leading role.  May support other auditors in planning, conduct and reporting of audits. 

• Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.

Inspection Support

• Participates in regulatory inspections in core and supporting roles

Training & Development

• Assists in preparation and delivery of training materials. Advises and contributes to coaching

• Completes training requirements in a timely manner to ensure inspection readiness at all times.

Project Management

• Takes an active role in projects as assigned by supervisor and interacts with key stakeholders as appropriate.

• Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress.

Expertise

• Provides expertise and knowledge to less experienced auditors, Business Partners and the core business sector on quality and compliance processes/procedures. Interprets and applies regulations/ policies to issues of moderate complexity, when required.

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, Coaching, Collaborating, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility