[Pfizer] Manager, GMP GDP Auditor

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