Quality Assurance Lead — GMP & Client Collaboration

WuXi XDC; Singapore; Sur place; SGD 120 000 - 180 000; Plein temps

Résumé du poste

WuXi XDC in Singapore seeks an experienced quality professional to manage issue tracking and client communications during GMP manufacturing. You will coordinate cross-functional teams to ensure timely and effective resolution and complete issue closure.

The role entails acting as the main client contact for quality systems, supporting client audits, managing regulatory documentation, and driving process improvements based on feedback and regulatory updates.

Qualifications

• Bachelor’s degree or higher in a scientific field.
• 8+ years of quality management experience in aseptic pharmaceutical manufacturing or biopharma.
• Strong knowledge of FDA, NMPA, EU GMP, and ICH guidelines.
• Familiarity with sterile manufacturing and quality management systems.
• Excellent communication and cross-functional coordination skills.
• Proficient with standard computer and office software.
• Strong English listening, speaking, reading, and writing skills.

Responsabilités

• Track, document, and close quality issues arising during GMP manufacturing and liaise with clients on status and progress.
• Provide client audit support, including pre-audit information, on-site accompaniment, and Q&A participation.
• Coordinate regulatory and quality documentation for MAH, BLA, and related submissions.
• Bridge clients and internal teams, respond to quality inquiries, and drive continuous improvement from feedback and regulatory updates.
• Oversee deviations, change controls, and CAPA with risk management and timely closure.
• Monitor GMP production batches and ensure delivery of batch records and related quality documentation.

Connaissances

Quality management

Regulatory knowledge

Cross-functional coordination

Excellent communication

English proficiency

Formation

Bachelor’s degree or higher in Chemistry/Biochemistry/Biology/Pharmaceutical Sciences/Biological Engineering

Outils

Office software

Description du poste

WuXi XDC in Singapore seeks an experienced quality professional to manage issue tracking and client communications during GMP manufacturing. You will coordinate cross-functional teams to ensure timely and effective resolution and complete issue closure.

The role entails acting as the main client contact for quality systems, supporting client audits, managing regulatory documentation, and driving process improvements based on feedback and regulatory updates.