QC Function Lead

Job Description

Act as QC project function lead to coordinate QC activities and ensure timely delivery.

Serve as key contact for clients, US QC team, and internal groups.

Manage timelines, track QC deliverables, and support CMC project execution.

Provide remote support to US QC operations across time zones.

· Oversee reference standard management and sample handling activities, ensuring proper qualification, lifecycle control, storage, and sample integrity compliance

Handle deviations, lab investigations, CAPA, and support audits/inspections.

Requirements

≥5 years QC experience in biologics.

Prior QC function lead/project lead experience preferred.

Strong project management and multitasking skills.

Excellent communication skills (English & Chinese).

Able to support remote collaboration with US teams.