Audit Lead
Core
Leading the design, delivery, and maintenance of GMP/GDP audit strategy for sterile biologics, medical devices, and small molecules to ensure regulatory compliance and risk identification.
Role type
Senior GMP/GDP Audit Lead (Sterile Biologics/Medical Device)
Builds
Independent GMP/GDP audits, inspection preparations, and risk-based action plans for Pfizer manufacturing and supply network.
Domain
Pharmaceutical/Biopharmaceutical Quality Assurance (GMP/GDP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GDP auditing, aseptic manufacturing expertise, regulatory intelligence analysis, risk assessment, audit strategy development, cross-functional project leadership, stakeholder management, technical writing, data analytics, critical thinking
Preferred skills
Master's degree, ASQ audit certification, internal audit/shop floor QA experience, Notified Body experience, Medical Device Regulations knowledge, cross-region project leadership
Technologies
FDA, EU Directive, ICH, TGA, PIC/S, ISO, Rizer
Responsibilities
Develop and implement technology-focused audit strategies; lead complex GMP/GDP audits at facilities and contract manufacturers; analyze regulatory intelligence and emerging risks; coach and oversee RQA and site-based auditors; prepare auditees for regulatory inspections; interpret regulatory challenges and recommend improvements; participate in industry forums and cross-functional initiatives.
Seniority
Senior, hands-on IC with strategic oversight
