Senior QA Lead – GMP & Quality Systems

Meiragtx; Greater London; On-site; GBP 70,000 - 95,000; Full time

Job summary

MeiraGTx seeks an experienced Senior QA professional to provide QA oversight to manufacturing operations in Greater London. The role ensures regulatory compliance, timely product releases and facilitates GMP documentation reviews.

The candidate will coach the QA team, maintain the QMS, and support internal and external audits. A strong background in sterile GMP environments and QMS systems is required.

Qualifications

• Minimum 5 years in a sterile GMP manufacturing environment.
• Strong understanding of Quality Management Systems and regulatory requirements.
• Experience with audits and regulatory inspections is essential.

Responsibilities

• Provide QA oversight to manufacturing operations and supporting functions.
• Manage the Quality Management System and related GMP documentation.
• Review and approve batch documentation and ensure timely GMP-compliant product releases.
• Develop and review QA processes, SOPs, policies and training materials.
• Lead QA KPIs, audits, and continuous improvement of the Quality system.

Skills

QA Oversight

GMP Compliance

Quality Management

Regulatory Inspections

Microsoft Office

Education

Bachelor's degree in Science

Tools

eQMS

QMS software

Document Management System

Job description

MeiraGTx seeks an experienced Senior QA professional to provide QA oversight to manufacturing operations in Greater London. The role ensures regulatory compliance, timely product releases and facilitates GMP documentation reviews.

The candidate will coach the QA team, maintain the QMS, and support internal and external audits. A strong background in sterile GMP environments and QMS systems is required.