Manager, GMP Audits

POSITION DESCRIPTION Identifying Position Information POSITION TITLE: (title reflected in Outlook and Pfizer Org Chart) Manager, GMP GDP Auditor REPORTS TO: (Manager’s Name) Director / Sr. Director, GMP GDP Audit Team Lead DATE COMPLETED/ REVIEWED 8/11/2025 DIVISION/BUSINESS LINE: Pfizer Global Supply & Quality SUB DIVISION: DEPARTMENT: Regulatory Quality Assurance LOCATION(S): (indicate all possible locations) Primary: Global – Any Pfizer site Is this a legacy Hospira position? ☐ Yes Other: Remote APPROVAL FROM SITE LEADERSHIP: (required for Cambridge Site) N/A ROLE DETAILS ROLE SUMMARY 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