Audit Lead
Pfizer
August 24, 2026
Remote
United States
Corporate Functions
Responsibilities:
- Lead design, delivery, and maintenance of GMP/GDP audit strategy for key technology/business areas (aseptic/sterile/biologics/biotechnology; sterile biologics; medical device including SaMD/digital health/medicines; small molecule; vendor/GDP).
- Ensure audit processes, systems, procedures, and auditor competencies align with regulatory expectations; identify risks and adapt to emerging regulations/industry trends.
- Independently lead GMP/GDP audits and inspection preparation; resolve findings; liaise with Site Quality and Above Site Quality teams across the audit lifecycle.
- Develop and implement technology-focused audit strategies/plans for complex audits; assess auditee compliance with GMP/GDP, Pfizer standards, Quality Agreements, and SOPs.
- Analyze regulatory intelligence and audit/inspection outcomes; create sustainable action plans and communicate new/emerging risks to RQA and PGS/PharmSci stakeholders.
- Coach/develop RQA and site-based auditors; review/approve audit reports; serve as Subject Matter Expert as needed.
- Partner with PGS and PharmSci/center functions to understand technology changes and identify emerging audit risks.
- Lead or participate in cross-functional projects and GMP/GDP assessments (e.g., due diligence, mock inspection, data integrity, quality culture); aid auditees with regulatory inspection preparation.
Qualifications (Basic):
- Bachelor’s degree in pharmaceutical sciences (or equivalent).
- 10+ years progressive experience in pharma/biopharma/medical device industry including quality control/assurance, manufacturing, and GMP/GDP auditing (may include Product Development).
- Aseptic manufacturing experience/expertise.
- Proven GMP/GDP auditing knowledge in at least 3 technology areas.
- Strong knowledge of GMP/GDP and relevant regulatory/audit frameworks (FDA, EU Directive, ICH, TGA, PIC/S, ISO) and ability to monitor emerging trends.
- Critical evaluation of auditee information; ability to identify risk areas and determine likely causes/solutions.
- Ability to make strategic/tactical recommendations and communicate across leadership levels; lead diverse/multicultural audit teams.
- Ability to work independently and conduct ad hoc GMP/GDP assessments.
Preferred:
- Master’s/advanced degree; recognized audit certification (e.g., ASQ); site internal audit/shop floor QA; BoH/Notified Body; Medical Device Regulations knowledge; cross-region/cross-functional audit project experience.
Application:
- Remote role. Last date to apply: May 6, 2026.
- Lead design, delivery, and maintenance of GMP/GDP audit strategy for key technology/business areas (aseptic/sterile/biologics/biotechnology; sterile biologics; medical device including SaMD/digital health/medicines; small molecule; vendor/GDP).
- Ensure audit processes, systems, procedures, and auditor competencies align with regulatory expectations; identify risks and adapt to emerging regulations/industry trends.
- Independently lead GMP/GDP audits and inspection preparation; resolve findings; liaise with Site Quality and Above Site Quality teams across the audit lifecycle.
- Develop and implement technology-focused audit strategies/plans for complex audits; assess auditee compliance with GMP/GDP, Pfizer standards, Quality Agreements, and SOPs.
- Analyze regulatory intelligence and audit/inspection outcomes; create sustainable action plans and communicate new/emerging risks to RQA and PGS/PharmSci stakeholders.
- Coach/develop RQA and site-based auditors; review/approve audit reports; serve as Subject Matter Expert as needed.
- Partner with PGS and PharmSci/center functions to understand technology changes and identify emerging audit risks.
- Lead or participate in cross-functional projects and GMP/GDP assessments (e.g., due diligence, mock inspection, data integrity, quality culture); aid auditees with regulatory inspection preparation.
Qualifications (Basic):
- Bachelor’s degree in pharmaceutical sciences (or equivalent).
- 10+ years progressive experience in pharma/biopharma/medical device industry including quality control/assurance, manufacturing, and GMP/GDP auditing (may include Product Development).
- Aseptic manufacturing experience/expertise.
- Proven GMP/GDP auditing knowledge in at least 3 technology areas.
- Strong knowledge of GMP/GDP and relevant regulatory/audit frameworks (FDA, EU Directive, ICH, TGA, PIC/S, ISO) and ability to monitor emerging trends.
- Critical evaluation of auditee information; ability to identify risk areas and determine likely causes/solutions.
- Ability to make strategic/tactical recommendations and communicate across leadership levels; lead diverse/multicultural audit teams.
- Ability to work independently and conduct ad hoc GMP/GDP assessments.
Preferred:
- Master’s/advanced degree; recognized audit certification (e.g., ASQ); site internal audit/shop floor QA; BoH/Notified Body; Medical Device Regulations knowledge; cross-region/cross-functional audit project experience.
Application:
- Remote role. Last date to apply: May 6, 2026.