Quality Assurance Manager (QA Manager) Department Quality Assurance Reports to Technical Director Team Product Quality Manager and System Quality Manager Mission Ensure compliance with regulatory and quality requirements by leading the Quality Management System and ensuring its correct implementation, maintenance and continuous improvement.
Represent the department before customers, health authorities and certification bodies.
Responsibilities Lead, organise and develop the QA team.
Define the department's objectives, KPIs and budget.
Maintain and improve the Quality System (GMP, ISO, FDA).
Oversee procedures, documentation and regulatory compliance.
Manage deviations, CAPAs, OOS/OOT, Change Control and Risk Management.
Ensure Data Integrity compliance (ALCOA+).
Take part in projects and manage customer relationships (QTAs, documentation).
Lead internal, external and health authority audits.




Oversee validations (IQ/OQ/PQ, CSV) and equipment qualification.
Drive continuous improvement and quality training.
Requirements Education Degree in Pharmacy, Chemistry, Medicine or similar.
Experience At least 10 years in Quality Assurance in regulated environments.
Team management experience.
Knowledge GMP (EU and FDA 21 CFR), ISO *, ISO *.
Validations (IQ/OQ/PQ, CSV).
Data Integrity, CAPA, OOS/OOT, Change Control, risk management.
Tools and languages ERP, document management systems and laboratory tools.
Native Spanish and a high level of English (French is a plus).
Competencies Leadership, decision-making, strategic vision, organisation, analytical thinking, communication and teamwork.

📌 Qa Manager (España)
🏢 Approach People Recruitment
📍 España