QA Compliance Officer

Overview

In this role you will uphold regulatory compliance for the Pharmaceutical Quality Management System across UK/EU/US GMP and ICH guidelines. You will work on improving quality processes, monitoring regulatory commitments, and supporting audits with a cross-functional team. The position is site-based in central Scotland, offering opportunities to influence QMS effectiveness and CAPA handling. You will collaborate with stakeholders to drive continuous improvement and maintain registrations and licenses.

Pay / Benefits

• enhanced pension
• healthcare
• flexi-time
• development and learning opportunities

Responsibilities

• Support quality system elements (QMS monitoring, supplier qualification, audits)
• Maintain and update regulatory registrations, licences, and certifications
• Track site compliance commitments and regulatory trends
• Collaborate with site functions to reduce compliance issues and drive improvements
• Review QMS documentation per global regulatory guidance
• Lead Quality Management Review meetings
• Support investigations and develop effective CAPA
• Prepare for regulatory and customer audits and support follow-up
• Escalate significant compliance concerns to Quality Management
• Build strong working relationships with stakeholders

Key requirements

• Degree or relevant qualification in a scientific, business, or engineering discipline
• Minimum 2 years’ experience in QA within a GMP environment
• Experience conducting internal or supplier audits
• Experience with QMS documentation (SOPs, deviations, investigations, CAPA)

• Strong attention to detail
• Problem-solving skills
• Excellent communication
• QMS documentation (SOPs, deviations, investigations, CAPA)
• Regulatory knowledge (GMP/GDP/ICH)
• Audit experience

…