Quality Assurance Specialist

WuXi XDC; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

WuXi XDC is looking for a proactive Manufacturing QA Specialist / Senior Specialist to join their Quality Assurance team in Singapore. This role includes overseeing compliance with GMP standards, validation, and quality systems, while requiring a strong background in QA/QC, particularly in biologics manufacturing. Candidates will be expected to have experience in regulatory compliance and quality oversight, contributing to both operational and strategic initiatives.

Qualifications

• 3 to 5+ years of QA/QC experience for Specialist level, 8 to 10+ years for Senior Specialist.
• Experience in biologics manufacturing and commercial supply; ADC experience is a plus for senior-level.
• Familiar with global GMP standards and regulatory requirements.

Responsibilities

• Ensure on-site GMP production and testing activities comply with internal procedures and global regulatory standards.
• Provide QA oversight for validation, qualification, and requalification activities.
• Lead or support the management of quality events: deviations, change controls, CAPA.

Skills

Problem-solving

Communication

Ownership mindset

Education

Bachelor’s degree or above in Biologics

Tools

Microsoft Office

Job description

Manufacturing QA Specialist / Senior Specialist

Job Summary

We are seeking proactive and detail-oriented individuals to join our Manufacturing Quality Assurance (MQA) team. You will oversee GMP manufacturing and testing activities, ensuring compliance with internal procedures and regulatory expectations. Based on your experience, you will take on responsibilities ranging from operational execution to strategic quality oversight.

Key Responsibilities

• Ensure on-site GMP production and testing activities comply with internal procedures and global regulatory standards (FDA, EMA, PICS).
• Contribute to the development and implementation of an effective quality system.
• Provide QA oversight for validation, qualification, and requalification activities.
• Review and approve manufacturing/testing-related documents and batch records.
• Authorize the release of facilities, utilities, and equipment for production use.
• Lead or support the management of quality events: deviations, change controls, CAPA, lab investigations.
• Assist with internal and external audits and inspections.
• Support cross-functional collaboration to maintain compliance and operational efficiency.

Qualifications

• Bachelor’s degree or above in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or related fields.
• For Specialist level: 3 to 5+ years of QA/QC experience, with at least 3 years in production QA.
• For Senior Specialist level: 8 to 10+ years of QA/QC experience, with at least 8 years in production QA.
• Experience in biologics manufacturing and commercial supply; ADC experience is a plus for senior-level candidates.
• Familiar with global GMP standards and regulatory requirements.
• Prior experience supporting new site startup is a plus.
• Strong communication, problem-solving, and ownership mindset.
• Proficient in Microsoft Office and fluent in English.