Kerja Sepenuh Masa, QA Senior Specialist, Quality System di WuXi XDC Southwest (Singapore) - Maukerja

Job Summary

• The Senior Specialist, Supplier Quality Management serves as the primary Point of Contact (POC) for supplier quality activities and supports the maintenance and continuous improvement of the Supplier Quality Management Program. The role is responsible for supplier qualification, supplier audit coordination and execution, supplier performance monitoring, supplier change notification management, quality agreement administration, and supplier lifecycle management to ensure compliance with applicable GMP regulations and company quality requirements. The position collaborates closely with cross functional team which includes Warehouse, Engineering, Validation, QC and affiliate sites to ensure effective supplier oversight and inspection readiness.

Responsibilities:

Supplier Qualification and Management

• Serve as the site POC for supplier qualification and supplier quality management activities.
• Coordinate and execute supplier qualification and requalification activities, including supplier questionnaires, quality assessments, risk evaluations, and document reviews.
• Liaise with internal stakeholders (Manufacturing, QC, Engineering, Validation, Warehouse, Procurement, and Quality functions) to support supplier qualification decisions.
• Review supplier documentation including business licenses, GMP certificates, ISO certifications, audit reports, quality manuals, and supporting compliance records.
• Leverage supplier qualification documentation and audit information from affiliate or global sites where applicable.
• Maintain the Approved Supplier List (ASL) and ensure supplier qualification records remain current and compliant.
• Support supplier lifecycle activities including qualification, periodic review, supplier change assessment, requalification, and decommissioning.

Supplier Audit Management

• Coordinate the site supplier audit program and maintain supplier audit schedules.
• Lead or support onsite, remote, and desktop supplier audits based on supplier criticality and risk.
• Prepare audit plans, agendas, audit reports, and supporting audit documentation.
• Track supplier audit observations, review supplier CAPA responses, and ensure timely closure of audit findings.
• Maintain supplier audit records, metrics, and compliance status to support management review and inspection readiness.

Supplier Performance Monitoring

• Perform periodic supplier performance monitoring and trending using predefined quality metrics and key performance indicators.
• Support supplier performance reviews and identify potential quality or compliance risks associated with supplier performance.
• Escalate significant supplier quality issues, compliance concerns, or performance trends to Quality Management.
• Participate in supplier quality investigations and cross-functional risk assessments as required.

Supplier Change Management and Quality Agreements

• Review and assess supplier change notifications for potential GMP, regulatory, validation, and product quality impact.
• Coordinate with relevant stakeholders to evaluate and implement required actions resulting from supplier changes.
• Draft, review, maintain, and periodically assess Quality Agreements (QAAs) with suppliers and service providers.
• Ensure supplier Quality Agreements are maintained in accordance with applicable company procedures and regulatory requirements.

Compliance and Continuous Improvement

• Support regulatory inspections, client audits, and internal audits related to supplier qualification and supplier quality management activities.
• Monitor supplier quality metrics and identify opportunities for process improvement.
• Support continuous improvement initiatives for supplier qualification, supplier auditing, and supplier oversight processes.
• Maintain knowledge of applicable FDA, EU GMP, PIC/S GMP, ICH, and company requirements related to supplier management.
• Perform other duties as assigned by Quality Management.

Qualifications:

• Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, Biological Sciences, Chemical Engineering, Bioengineering, or related discipline.
• Minimum 5 to 8 years of experience in Quality Assurance, Supplier Quality, Quality Systems, or GMP manufacturing within the pharmaceutical, biotechnology, or biologics industry.
• Minimum 3 years of experience in supplier qualification, supplier quality management, or supplier audit activities.
• Experience conducting or supporting supplier audits is preferred.
• Experience with biologics, sterile manufacturing, CDMO/CRDMO operations, or commercial GMP quality systems is preferred.

Technical Knowledge

• Knowledge of FDA, EU GMP, PIC/S GMP, ICH guidelines, and supplier quality management requirements.
• Understanding of supplier qualification, risk assessment, supplier auditing, CAPA, deviation management, change control, and quality agreements.
• Familiarity with electronic quality systems such as TrackWise, Veeva, SAP, and Microsoft Office applications.