Responsibilities

•    Act as a point-of-contact (POC) and subject matter expert (SME) for clinical quality requirements and activities in China for assigned portfolios, studies, or vendors.
•    Implement strategies and activities related to inspection readiness and audit response management for clinical development conducted in China.
•    Lead the development of Risk/Quality Plans for Development China functions and the China clinical trial portfolio and associated key vendors when needed.
•    Support GCP quality event reporting, assessment, investigation, and remediation activities for GCP quality issues related to China clinical development activities.
•    Develop and deliver GCP quality relevant training as needed

Minimal/Must-have Requirement

•    A scientific or technical degree; an advanced degree (MS/MD/PhD) is preferred.
•    Extensive clinical development and business experience that demonstrates a thorough understanding of the processes associated with clinical and regulatory operations.
•    Knowledge of local and international regulatory requirements, especially intensive experience in CFDI/FDA Inspection.
•    At least 5 years of increasingly responsible positions in Clinical Operation and/or Clinical Development Quality.

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