# Regulatory Quality Assurance (RQA) GMP GDP Auditor

**Company**: Pfizer
**Location**: Aichi, Japan
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Finance
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/Japan---Aichi/XMLNAME--Pfizer--Manager--GMP-GDP-Auditor_4962617-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_ab24a7ee-bb6

## Description

We are seeking a Regulatory Quality Assurance (RQA) GMP GDP Auditor to join our team. As an independent Quality audit function, RQA is accountable for identifying risks and non-compliance associated with Pfizer's GxP regulated operations.

The successful candidate will be responsible for:

- Independently planning and leading complex audits of material suppliers, service providers, and Pfizer Country Offices

- Participating in audits of low-complexity commercial or clinical manufacturing sites and contract manufacturers

- Performing initial and routine audits, and managing and leading with minimal oversight

- Leveraging AI tools to support targeted audit preparation and execution

- Engaging with complex audits, including process audits, or serving as a reviewer of low-complexity, outsourced audits

- Supporting and executing quality programs related to functional areas, specific vendor entities, and/or assessments

- Applying GMP working knowledge to resolve issues based on relevant SOPs, GMP GDP regulations/standards, and local regulations and standards

- Collaborating with RQA colleagues on cross-GxP audit plans as required

- Managing multiple stakeholders to synthesize feedback and take action with support from the Manager

The ideal candidate will have:

- A BS in pharmaceutical or natural sciences, or equivalent

- Advanced knowledge and understanding of global regulations and international standards

- Comprehensive working knowledge of business concepts and quality operations

- Ability to think critically and identify areas of greatest risk

- Proficient organizational and project management skills

- Technical writing skills

- Ability to identify trends within data and apply insights to make recommendations

- Specialization in at least one conventional technology (e.g., API, solid oral dosages)

Preferred qualifications include:

- 5-7 years of experience in operational or auditing roles

- Working knowledge of data analytics and interpretation capabilities

- Expertise in vendor audits and at least one technology area (e.g., MDCP, sterile biologics, small molecules, GDPs)

- Ability to function autonomously in a matrix model and in a team environment

- Fluency in both Japanese and English languages

This is a field-based position that requires walking, observing, and assessing quality and compliance risks. The successful candidate will be able to travel up to 40% of the time, including domestic and international travel.

## Skills

### Required
- GMP
- GDP
- audit
- quality assurance
- regulatory compliance
- pharmaceuticals
- natural sciences
- Japanese

### Nice to have
- data analytics
- vendor audits
- MDCP
- sterile biologics
- small molecules
- GDPs

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/Japan---Aichi/XMLNAME--Pfizer--Manager--GMP-GDP-Auditor_4962617-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)