Senior QC Lead – Raw Materials & Compliance Expert

WuXi Biologics; Singapore; On-site; SGD 150,000 - 210,000; Full time

Job summary

WuXi Biologics seeks a senior QC/ RM leader to oversee raw materials and compendial testing teams, ensuring timely delivery and high-quality results across cGMP-compliant operations.

Responsibilities include budgeting with the QC head, SOP and protocol reviews, and guiding regulatory submissions while maintaining GDP and PIC/S guidelines adherence. Strong SME in RM control and analytical testing is required.

Qualifications

• Bachelor of Science degree in Chemistry, Microbiology, Biochemistry or equivalent.
• 6–8 years of QC experience in biopharmaceuticals with 2+ years in management.
• Knowledge of GMP, ICH and pharmacopoeia guidelines for RM/Compendia specifications.

Responsibilities

• Lead RM and Compendial testing teams; plan schedules and resource assignments.
• Review SOPs, validation protocols, investigations (OOS/OOL) and specifications.
• Ensure procedures comply with GDP, cGMP, CFR and PIC/S guidelines.
• Draft and review CMC sections for regulatory submissions (e.g., BLAs).
• Develop and oversee QC training programs for cGMP and testing techniques.

Skills

GMP knowledge

cGMP proficiency

Quality systems

Root cause analysis

Education

Bachelor of Science in Chemistry/Biochemistry/Microbiology

Advanced graduate degree

Tools

LIMS

Validation protocols

Job description

WuXi Biologics seeks a senior QC/ RM leader to oversee raw materials and compendial testing teams, ensuring timely delivery and high-quality results across cGMP-compliant operations.

Responsibilities include budgeting with the QC head, SOP and protocol reviews, and guiding regulatory submissions while maintaining GDP and PIC/S guidelines adherence. Strong SME in RM control and analytical testing is required.