Senior Quality Assurance Specialist

We are seeking a talented Quality professional to join a global medicines organisation supporting affiliate-level quality operations across regions. This is an exciting opportunity to work at the intersection of quality, compliance, and business operations, ensuring global standards are effectively implemented at the local level.

You will act as a trusted quality partner, embedding quality systems into business processes, driving compliance, and supporting inspection readiness across diverse markets.

This role is available at Associate, Senior Associate, or Principal level, depending on experience.

• Support the development and implementation of local and regional quality systems aligned with global standards
• Manage key quality processes including deviations, CAPA, change control, and quality documentation
• Interpret and apply regulatory requirements (GxP) across business activities

• Monitor compliance and proactively identify risks, gaps, and improvement opportunities
• Perform trend analysis and recommend corrective and preventative actions
• Contribute to risk assessments, quality plans, and continuous improvement initiatives

• Support and coordinate internal and external audits and inspections
• Ensure teams are inspection-ready with appropriate documentation and processes
• Manage audit responses and ensure timely closure of CAPAs

• Act as a quality advisor to cross-functional teams
• Support teams in interpreting regulatory and quality requirements
• Build strong relationships across affiliate and global teams
• Drive process improvements and simplification initiatives
• Identify opportunities to enhance quality systems and workflows
• Share best practices across regions and global teams

• Degree in a Life Sciences or Healthcare-related field (e.g. Pharmacy, Nursing, Biomedicine)
• Experience in quality, clinical development, pharmacovigilance, or regulatory environments
• Strong knowledge of GxP frameworks (GMP, GCP, and/or GVP)
• Experience with:
• CAPA, deviations, and change control
• Quality systems and compliance processes
• Strong analytical, problem-solving, and communication skills
• Ability to manage multiple priorities in a dynamic, global environment

• Experience in affiliate or regional quality roles
• Exposure to audit/inspection management
• Familiarity with risk-based decision-making approaches
• Experience working in global or matrix organisations

If this is something you're interested in, apply or get in touch -