R&D QA Manager — Lead Quality for Drug & Device Programs

EyeD Pharma; Luik; Sur place; EUR 90 000 - 140 000; Plein temps

Avantages offerts par ce poste

Permanent position

Full-time

Résumé du poste

EyeD Pharma is seeking an experienced R&D QA Manager to lead quality activities across development programs and registrations. The role requires ensuring compliance with EMA/FDA standards, ICH guidelines and ISO 13485/14971, while driving improvements in our QA processes.

Key responsibilities include leading QA activities, maintaining the QMS, managing audits and supplier collaborations, and ensuring effective communication with multiple stakeholders in a fast-paced environment.

Qualifications

• Master-level degree or equivalent in a relevant scientific field.
• Minimum 5 years in quality roles within pharmaceutical or medical device environments.
• Minimum 2 years in a leadership role.
• Knowledge of EMA/FDA requirements, ICH, ISO 13485 and ISO 14971.
• Fluent in French and professional English.
• Experience with developing and implementing quality systems and risk management.

Responsabilités

• Lead and direct R&D QA activities to meet goals and compliance.
• Promote Quality Culture and provide guidance across teams.
• Coordinate with other departments to ensure alignment and regulatory readiness.
• Oversee Quality Management System, CAPAs, changes, deviations, and documentation.
• Prepare and manage internal audits and inspections by authorities.

Connaissances

Leadership

Quality compliance

Risk management

Pharma/medical device QA

Documentation management

Audit readiness

Cross-functional communication

Bilingual French/English

Formation

Master of Sciences in Chemistry, Engineering, Pharmacy, Pharmaceutical and Biomedical Sciences

Outils

Veeva Vault

Description du poste

EyeD Pharma is seeking an experienced R&D QA Manager to lead quality activities across development programs and registrations. The role requires ensuring compliance with EMA/FDA standards, ICH guidelines and ISO 13485/14971, while driving improvements in our QA processes.

Key responsibilities include leading QA activities, maintaining the QMS, managing audits and supplier collaborations, and ensuring effective communication with multiple stakeholders in a fast-paced environment.