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 manufacturing and distribution operations, Pfizer license entities, Pfizer country offices, material suppliers, service providers, commercial/clinical manufacturing sites and contract manufacturers that are involved in GMP/ GDP 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 and distribution 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/participates in audits of Pfizer manufacturing and distribution operations, Pfizer license entities, Pfizer country offices, material suppliers, service providers, commercial/clinical manufacturing sites and contract manufacturers performing initial and routine audits, managing/leading 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 GDP 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
- Extensive expertise in good distribution practices with complex global distribution models, partners and license entities. Knowledge of MAH and WDA regulatory requirements.
- 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 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 QUALIFICATIONS5-7 years of experience (operational or auditing preferred)Exhibits working knowledge of data analytics and interpretation capabilitiesExpertise in vendor audits plus 1+ technology area (MDCP, sterile biologics, small molecules, GDP’s)Ability to function autonomouslyin a matrix model and in a team environmentundefined
PHYSICAL/MENTAL REQUIREMENTS
- Primarily a field-based position which includes walking, observing (physically and electronically) and lifting 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.
ORGANIZATIONAL RELATIONSHIPS
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- Collaborate with colleagues across RQA and auditees from different functional lines within Pfizer and/or vendors
RESOURCES MANAGED
Financial Accountability
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Supervision
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- No direct and/or indirect reports are managed by this position
Work Location Assignment: Remote
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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Quality Assurance and Control