品保部 QA Manager/Sr. Manager

The Senior Manager, GMP Manufacturing Quality Assurance (QA) is responsible for overseeing the end-to-end quality lifecycle of GMP manufacturing operations, including raw materials, components, in-process intermediates, and finished goods. This role ensures that all manufacturing activities, materials, and facilities comply strictly with global regulatory requirements (FDA, EMA, ICH) and internal quality standards.

Job Description
#External Partner & CDMO Quality Oversight

• CDMO & Lab Management: Serve as the primary QA point of contact and relationship manager for CDMOs and contract testing laboratories.
• External Deviations: Review and approve major/critical deviations, Out-of-Specification (OOS) results, and investigations generated by CDMOs, ensuring robust root cause analysis.

#Manufacturing QA & Quality Systems Governance

• Batch Record Review: Oversee the meticulous review of Master Batch Records (MBRs) and Executed Batch Records (EBRs) to ensure data integrity and regulatory compliance.
• Change Control Management: Evaluate and approve complex Change Controls related to manufacturing processes, materials, analytical methods, and equipment.
• CAPA Ownership: Drive the timely implementation and effectiveness verification of Corrective and Preventive Actions (CAPAs) resulting from deviations and audits.
• Metrics & Reporting: Own and report Quality Key Performance Indicators (KPIs) related to manufacturing and material quality for Site Quality Management Reviews (QMR).
• QRM Leadership: Facilitate, review, and approve formal Quality Risk Assessments (e.g., FMEA, PHA) for manufacturing processes, facility modifications, tech transfers, and material sourcing.
• Risk-Based Decision Making: Apply risk management principles to justify and defend QA dispositions, complex deviation justifications, and sampling plans.
• Contamination Control Strategy (CCS): Oversee, maintain, and enforce the site’s Contamination Control Strategy to mitigate microbial, particulate, and product-to-product cross-contamination risks in multi-product facilities.