QA Manager – Pharma / Cosmetics Quality Assurance (GMP), Barcelona

Approach People; Barcelona; On-site; EUR 70,000 - 95,000; Full time

Job summary

Approach People Recruitment seeks a Quality Assurance Manager to lead the QA department and ensure GMP, ISO, and FDA compliance across activities in a regulated environment. You will oversee audits, CAPAs, data integrity, and change control while driving continuous improvement and liaising with health authorities.

The role requires a pharmacy/chemistry/medicin e background and a minimum of 10 years QA leadership experience, with strong English skills and team management ability.

Qualifications

• 10+ years of QA experience in regulated environments.
• Experience leading QA teams and budgets.

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.

Skills

Leadership

Team management

Analytical thinking

Communication

Decision-making

Strategic vision

Organisation

Teamwork

Education

Degree in Pharmacy/ Chemistry/ Medicine

Tools

ERP

Document management systems

Laboratory tools

Job description

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.