Senior QA Drug Substance Operations Lead

WuXi Biologics; Dundalk; On-site; EUR 90,000 - 110,000; Full time

Job summary

WuXi Biologics in Dundalk, Ireland seeks a Senior QA Drug Substance Operations Specialist to provide online QA oversight of Drug Substance manufacturing operations. You will ensure compliance with cGMP and internal SOPs while supporting technology transfer, change controls, deviations, investigations and batch reviews to maintain high-quality drug substance production.

The role involves collaboration with Manufacturing Operations, QA, QC, Engineering and MSAT, and includes preparation for

Qualifications

• Strong knowledge of cGxP requirements and regulations.
• Experience in biotechnology/pharmaceutical quality operations.
• Ability to interpret and review technical documentation.
• Demonstrated communication and collaboration skills.

Responsibilities

• Provide online QA oversight to Drug Substance manufacturing operations.
• Perform QA review of SOPs, risk assessments, change controls and other documentation.
• Ensure operations comply with cGMP and SOPs.
• Liaise with Manufacturing Operations to address deviations, investigations, and batch reviews.
• Support CAPAs, change controls, and internal/external inspections.
• Support regulatory submissions and inspection readiness activities.
• Act as substitute for QA DS Operations group lead as required.
• Support recruitment activities and cross-functional projects.

Skills

Analytical thinking

Communication

Problem solving

Technical interpretation

Adaptable

Education

Bachelor's degree in a technical discipline

Tools

Quality Management System (QMS) tools

Job description

WuXi Biologics in Dundalk, Ireland seeks a Senior QA Drug Substance Operations Specialist to provide online QA oversight of Drug Substance manufacturing operations. You will ensure compliance with cGMP and internal SOPs while supporting technology transfer, change controls, deviations, investigations and batch reviews to maintain high-quality drug substance production.

The role involves collaboration with Manufacturing Operations, QA, QC, Engineering and MSAT, and includes preparation for