QA / Quality Director

About the role

We are seeking a senior Quality Assurance leader to head our QA function in Spain. The role will ensure compliance with EU GMP, GDP and other regulatory requirements across our pharmaceutical, food supplement and healthcare product portfolio.

Key responsibilities

• Lead and manage the Quality Assurance department, driving continuous improvement of the Quality Management System.
• Maintain GMP/GDP compliance and ensure inspection readiness for regulatory, customer and internal audits.
• Oversee deviation management, CAPA, change control, risk management and quality event investigations.
• Review, approve and control the lifecycle of GMP documentation such as SOPs, specifications, batch records, validation files and quality agreements.
• Support batch release by verifying all required quality documentation and compliance checks.
• Supervise supplier qualification, contract‑manufacturer oversight and periodic performance reviews.
• Coordinate internal audits and monitor timely closure of audit observations and CAPA effectiveness.
• Provide QA oversight for manufacturing, packaging, laboratory, warehouse and distribution activities.
• Assist regulatory submissions and authority responses from a quality documentation perspective.
• Ensure GMP/GDP training systems are in place and lead quality review meetings, KPI reporting and management reviews.

Required profile

• University degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Life Sciences or a related scientific discipline.
• Minimum 5 years of experience in pharmaceutical Quality Assurance, Quality Control or GMP manufacturing.
• Previous experience in a Quality Manager, QA Manager, Head of QA or Quality Director role is strongly preferred.

Required skills

• In‑depth knowledge of EU GMP and GDP regulations.
• Experience with CAPA, deviation management, change control and risk management.
• Proficiency in supplier qualification, audit coordination and document lifecycle management.
• Ability to support batch release and regulatory submissions.
• Strong understanding of validation, SOPs, specifications and quality agreements.