Quality Assurance Manager

ELMEA Consulting Group; Brussel Hoofdstad; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A consulting firm in Brussel Hoofdstad is seeking an experienced Quality Assurance Manager to support clients in enhancing their Quality Management Systems. The ideal candidate will manage QMS according to GMP/ISO standards and lead audits while ensuring compliance with EU GMP and FDA regulations. Candidates should have at least 5 years of QA experience in the pharma or biotech sectors, with strong leadership skills and fluency in English. Knowledge of French or Dutch is an advantage.

Qualifications

• Minimum 5 years of experience in a QA role within pharma, biotech, or medical devices.
• In-depth knowledge of GMP regulations, ICH guidelines, and ISO standards.
• Fluent in English; French and/or Dutch is a plus.

Responsabilités

• Manage and maintain the Quality Management System in accordance with GMP/ISO standards.
• Plan and lead internal and external audits.
• Handle deviations, non-conformances, CAPAs, and change control processes.
• Review and approve SOPs, batch records, and other controlled documents.

Connaissances

GMP/ISO knowledge

Leadership skills

Communication skills

Knowledge of ICH guidelines

Audit management

Formation

Degree in pharmacy, life sciences, engineering or equivalent

Description du poste

We are looking for an experienced Quality Assurance Manager to support our clients in maintaining and improving their Quality Management Systems in regulated Life Sciences environments. The consultant will act as a key quality partner, driving compliance, audit readiness, and continuous improvement initiatives across the organisation.

• Manage and maintain the Quality Management System (QMS) in accordance with GMP/ISO standards
• Plan and lead internal and external audits; manage supplier qualification programs
• Handle deviations, non-conformances, CAPAs, and change control processes
• Review and approve SOPs, batch records, and other controlled documents
• Ensure compliance with applicable regulations (EU GMP, FDA, ICH guidelines)
• Act as key contact during regulatory inspections and health authority visits
• Train and coach operational teams on quality standards and drive continuous improvement

Required profile.

• Degree in pharmacy, life sciences, engineering, or equivalent
• Minimum 5 years of experience in a QA role within pharma, biotech, or medical devices
• In-depth knowledge of GMP regulations, ICH guidelines, and ISO standards (ISO 13485 is a plus)
• Proven experience with audits, CAPA management, and change control
• Strong leadership and communication skills
• Fluent in English; French and/or Dutch is a plus