Drive GCP Quality by maintaining quality oversight for assigned clinical trial programs/protocols
Oversee study-level quality risk management activities including Study Risk Profile development
Provide Study Team Inspection Readiness guidance and support
Develop inspection readiness tools and processes
Communicate key quality information across study teams
Collaborate with cross functional study team and drive quality risk management activities
Lead asset level/study level quality risk planning activities

Requirements

A scientific or technical degree is preferred
BS: 10+ years or equivalent
MS/MBA: 7+ years or equivalent
Strong, advanced knowledge, experience and expertise in ICH GCP, clinical trial development, and operational GCP quality management disciplines
Familiarity with relevant key therapeutic area(s)
Oncology experience strongly preferred
Advanced clinical trials experience, especially operational processes and/or systems
Strong interpersonal skills, ability to influence, engage leaders and establish and maintain excellent working relationships
Experience of working on global initiatives or project teams
Extensive knowledge of regulations to assess GCP situations and coordinate resolution activities
Excellent knowledge of Pfizer SOPs and quality management processes
Extensive Quality related experience including working knowledge in areas of: Quality and compliance management, QC Root Cause Analysis, Metrics development and utilization, Audit and Inspection conduct, CAPA development and response process, Inspection Readiness, Project/initiative coordination and management skills, Spotfire and Excel skills/experience

Benefits

401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits including medical, prescription drug, dental and vision coverage

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

ICH GCPclinical trial developmentoperational GCP quality managementQuality and compliance managementQC Root Cause AnalysisMetrics developmentAudit and Inspection conductCAPA developmentInspection Readinessproject management

Soft Skills

interpersonal skillsinfluenceengagementrelationship buildingcommunication