Pfizer

[Pfizer] Manager, GMP GDP Auditor

Posted Yesterday

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Hiring Remotely in Aichi, JPN

Remote

Senior level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Leads complex GMP/GDP audits of Pfizer facilities, suppliers, contract manufacturers, service providers, and country offices worldwide. Plans audit activities, assesses compliance risks, evaluates regulations and quality systems, documents findings, synthesizes stakeholder feedback, and supports corrective actions and quality programs. Uses AI tools with human oversight to improve audit preparation and execution, contributes to digital workflow improvements, identifies trends, and collaborates across GxP audit plans. The field-based role requires up to 40% domestic and international travel.

Summary Generated by Built In

ROLE SUMMARY
Regulatory Quality Assurance (RQA) is an independent Quality audit function accountable to identify risks and non-compliance associated with Pfizer's GxP regulated operations. Within RQA, the GMP GDP Audit function is responsible for performing GMP /GDP audits of Pfizer facilities, contract manufacturers, suppliers and GMP/GDP service providers involved in the manufacturing, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products worldwide. The RQA GMP GDP Audit function is accountable to ensure Pfizer manufacturing operations are compliant with all applicable global GMP/GDP regulations/standards and Pfizer Quality Standards. The RQA GMP GDP Audit function is required to understand GMP /GDP regulations worldwide and apply this expertise when performing audits, to provide assurance against regulator's interpretation and expectations for compliance with cGMP/GDP requirements.
ROLE RESPONSIBILITIES

Independently plans/leads more complex audits of material suppliers, service providers and Pfizer Country Offices, participates in audits of low complexity commercial/clinical manufacturing sites and contracts manufacturers, performs initial and routine audits, and manages/leads with minimum oversight
Leverages responsible use of AI tools to support targeted audit preparation and execution
May engage with more complex audits including process audits or serve as a reviewer of low complexity, outsourced audits
Supports and executes on quality programs related to functional areas, specific vendor entities and/or assessments
Has GMP working knowledge and is called upon to resolve issues based on knowledge of relevant SOPs (Standard Operating Procedures), GMP GDP regulations/standards, as well as local regulations and standards
Works with RQA colleagues on cross GxP audit plans as required
Ability to manage multiple stakeholders to synthesize feedback and take action with support from Manager

BASIC QUALIFICATIONS

BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
Demonstrates advanced knowledge and understanding of global regulations (e.g., FDA, ICH, PIC's, EMA, HC, ANVISA, TGA) and international standards (e.g., ISO, WHO)
Applies human oversight, professional judgment, and source verification when using AI tools to support audit planning, execution, reporting, and follow-up
Demonstrates willingness to adopt new audit technologies and contribute to continuous improvement of digital audit workflows and methodologies
Demonstrates willingness to adopt new audit technologies and contribute to continuous improvement of digital audit workflows and methodologies.
Demonstrates comprehensive working knowledge of business concepts and quality operations
Ability to think critically to identify and assess areas of greatest risk and develop a strategic approach to audit based on compliance and business knowledge
Understands quality and auditing frameworks and application
Exhibits proficient organizational and project management skills
Demonstrates technical writing skills
Ability to identify trends within data and apply insights to make recommendations
Actively identifies areas to assess for greater risk to support senior auditor positions in driving outcomes
Ability to synthesize information and draw conclusions
Suggests new audit techniques and approaches, and operationalizes to improve the audit system
Specializes in at least one conventional technology (e.g., API, solid oral dosages)

PREFERRED QUALIFICATIONS

5-7 years of experience (operational or auditing preferred)
Exhibits working knowledge of data analytics and interpretation capabilities
Expertise in vendor audits plus 1+ technology area (MDCP, sterile biologics, small molecules, GDP's)
Ability to function autonomously in a matrix model and in a team environment
Ability to communicate in both Japanese and English language to a high standard.

PHYSICAL/MENTAL REQUIREMENTS

Primarily a field-based position which includes walking, observing (physically and electronically) to assess quality and compliance risks.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to travel up to 40% of the time, including domestic and international traveling.

Work Location Assignment: Remote - Field Based
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control

Skills Required

Bachelor of Science degree or equivalent, preferably in pharmaceutical or natural sciences
Advanced knowledge of global regulations, including FDA, ICH, PIC/S, EMA, Health Canada, ANVISA, and TGA requirements
Knowledge of international standards, including ISO and WHO standards
Ability to apply human oversight, professional judgment, and source verification when using AI tools for audit activities
Willingness to adopt new audit technologies and improve digital audit workflows and methodologies
Comprehensive working knowledge of business concepts and quality operations
Critical-thinking ability to identify risks and develop strategic audit approaches
Knowledge of quality and auditing frameworks and their application
Organizational and project management skills
Technical writing skills
Ability to identify data trends and apply insights to recommendations
Ability to assess high-risk areas and support senior auditor outcomes
Ability to synthesize information and draw conclusions
Ability to suggest and operationalize improved audit techniques
Specialization in at least one conventional technology area, such as APIs or solid oral dosage forms
5–7 years of operational or auditing experience
Working knowledge of data analytics and interpretation
Expertise in vendor audits and at least one technology area, such as sterile biologics, small molecules, or GDP
Ability to work autonomously in a matrix and team environment
High-standard Japanese and English communication skills

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.