Responsible for driving GCP Quality by maintaining ‘quality’ line-of sight for assigned clinical trial programs/protocols
Ensure program and study level quality oversight
Drive quality risk management and inspection readiness activities
Provide Study Team Inspection Readiness guidance and support
Develop and maintain inspection readiness tools and processes
Provide strategic input to risk-based quality approaches
Communicate key quality information across study teams

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
Familiarity with the relevant key therapeutic area(s)
Advanced clinical trials experience, especially operational processes and/or systems
Strong interpersonal skills, ability to influence and engage leaders
Extensive knowledge of regulations to assess GCP situations and coordinate resolution activities across partner lines
Extensive Quality related experience including working knowledge in areas of Quality and compliance management, QC Root Cause Analysis, Metrics development and utilization, CAPA development and response process, Audit and Inspection conduct, Inspection Readiness, Project/initiative coordination and management skills, Spotfire and Excel skills/experience

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
Participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary
Eligibility for share based long term incentive program

Asset Quality Lead – Director

Key skills