Quality Control Principal Specialist, Raw Materials & Compendial

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 is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.

Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.

Key Responsibilities

• Lead the Raw Materials and Compendial testing teams, including hiring, onboarding, mentoring, and performance evaluations.
• Supervise, plan, and coordinate daily work schedules and resource assignments for staff.
• Partner with the QC Head to manage budgeting for manpower, supplies, and equipment.
• Oversee all RM and compendia testing activities to ensure product quality and timely delivery of results.
• Establish and monitor Operational Metrics and Service KPIs to ensure department objectives are met.
• Direct continuous improvement initiatives focused on quality, cost savings, and process efficiency.
• Provide guidance on analytical method qualification/validation and troubleshoot laboratory issues.
• Review and approve SOPs, validation protocols, investigations (OOS/OOL), and specifications.
• Ensure all laboratory procedures comply with GDP, cGMP, CFR, and/or PIC/S guidelines.
• Draft and review relevant CMC sections for regulatory submissions (e.g., BLAs).
• Serve as the Site Point of Contact (POC) and SME for RM and Compendia topics.
• Participate in Global Center of Excellence (COE) meetings to align site practices with global standards.
• Develop and oversee QC training programs to ensure team proficiency in cGMP and specialized testing techniques.

Requirement

• Bachelor of Science degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.
• 6 - 8 years of relevant experience in QC in biopharmaceutical industry and 2 years of Management experience is required. .
• Knowledge of GMP regulations, ICH regulations and pharmacopoeia (EP/USP/ChP, etc) for Incoming materials/Raw material (RM)/Compendia specification generation.
• Subject matter expertise (SME) and hands-on proficiency with all aspects of pharmaceutical RM control.
• Experience and understanding RM regulations and guidelines with in-depth understanding of cGMP.
• Experience in validating and executing RM testing methods, identification methods, and evaluating new technology or methods.
• Be proficient in technique and principle of compendial testing, including pH, Osmolality, Clarity, extractable volume, visible particles, Color, Subvisible particulate Matter, etc.
• Experience with application of root cause analysis tools for investigation execution.
• Experience with Quality Systems (e.g. Document/Quality/Learning management system, Change Control, Deviations, and CAPA programs).
• Able to rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.