QA Manager — Life Sciences Compliance & Audits

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

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.