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