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 13485, ISO 22716.
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 – Pharma / Cosmetics Quality Assurance (GMP), Barcelona