Audit Lead
Pfizer
August 24, 2026
Remote
United States
Corporate Functions
Responsibilities:
- Lead design, delivery, and maintenance of GMP/GDP audit strategy for technology/business areas (aseptic/sterile biologics/biotechnology; medical device including SaMD/digital health; small molecule; vendor/GDP).
- Ensure audit processes, systems, and auditor competencies align with regulatory expectations; identify risks and emerging trends.
- Partner with Pfizer Global Supply (PGS) and Pharm Sci to align GMP/GDP expectations and manufacturing/supply capabilities.
- Lead independent GMP/GDP audits and inspection preparation; resolve audit/inspection findings; coordinate with Site/Above Site Quality teams through the audit lifecycle.
- Coach/develop RQA and site-based auditors; review/approve audit reports; serve as Subject Matter Expert.
- Lead/participate in complex cross-functional projects; incorporate audit outcomes and best practices across the network.
- Conduct GMP/GDP assessments (e.g., due diligence, mock inspections, data integrity, quality culture) and support auditees for regulatory readiness.
Qualifications:
- 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.
- Demonstrated GMP/GDP auditing knowledge across 3+ technology areas.
- Strong knowledge of GMP/GDP and relevant regulatory/audit frameworks (e.g., FDA, EU, ICH, TGA, PIC/S, ISO) with ability to monitor emerging regulations.
- Strong analytical, critical thinking, stakeholder management, leadership, and communication skills; ability to work independently and lead global teams.
Preferred:
- Master’s/advanced degree; recognized audit certification (e.g., ASQ); site internal audit/shop-floor QA; BoH/Notified Body experience; medical device regulations knowledge; cross-region/cross-functional audit project experience.
Application/Logistics:
- Remote.
- Travel up to 40%.
- Last date to apply: May 6, 2026.
- Lead design, delivery, and maintenance of GMP/GDP audit strategy for technology/business areas (aseptic/sterile biologics/biotechnology; medical device including SaMD/digital health; small molecule; vendor/GDP).
- Ensure audit processes, systems, and auditor competencies align with regulatory expectations; identify risks and emerging trends.
- Partner with Pfizer Global Supply (PGS) and Pharm Sci to align GMP/GDP expectations and manufacturing/supply capabilities.
- Lead independent GMP/GDP audits and inspection preparation; resolve audit/inspection findings; coordinate with Site/Above Site Quality teams through the audit lifecycle.
- Coach/develop RQA and site-based auditors; review/approve audit reports; serve as Subject Matter Expert.
- Lead/participate in complex cross-functional projects; incorporate audit outcomes and best practices across the network.
- Conduct GMP/GDP assessments (e.g., due diligence, mock inspections, data integrity, quality culture) and support auditees for regulatory readiness.
Qualifications:
- 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.
- Demonstrated GMP/GDP auditing knowledge across 3+ technology areas.
- Strong knowledge of GMP/GDP and relevant regulatory/audit frameworks (e.g., FDA, EU, ICH, TGA, PIC/S, ISO) with ability to monitor emerging regulations.
- Strong analytical, critical thinking, stakeholder management, leadership, and communication skills; ability to work independently and lead global teams.
Preferred:
- Master’s/advanced degree; recognized audit certification (e.g., ASQ); site internal audit/shop-floor QA; BoH/Notified Body experience; medical device regulations knowledge; cross-region/cross-functional audit project experience.
Application/Logistics:
- Remote.
- Travel up to 40%.
- Last date to apply: May 6, 2026.