Vendor Quality Specialist – Life Sciences (GCP)

Capgemini; Diegem; Sur place; EUR 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Harvard Business Review access

Mentoring programs

Extensive training library

Résumé du poste

Capgemini Engineering is seeking a Vendor Quality Specialist to support GCP vendor qualification, Quality Agreement lifecycle, and CAPA management within a regulated pharmaceutical environment. The role collaborates with Procurement, Legal and Quality Leads to ensure compliance with EMA, FDA and ICH guidelines, while driving process improvements and digital quality initiatives across vendor management.

The successful candidate brings strong GCP knowledge, extensive vendor oversight experience,

Qualifications

• Minimum 5 years in GCP quality within clinical trials.
• Proven vendor quality management experience.
• Experience drafting and maintaining Quality Agreements.
• Strong knowledge of ICH, EMA and FDA regulations.
• Proficient with digital quality systems and IT tools.
• Excellent communication and organizational skills.

Responsabilités

• Support vendor qualification activities and risk-based assessment.
• Oversee Quality Agreements lifecycle from creation to closure.
• Act as quality contact for deviations, investigations and CAPA.
• Ensure GCP compliance with EMA, FDA and ICH guidelines.
• Support digital quality initiatives and IT-based governance.

Connaissances

GCP knowledge

Vendor quality management

CAPA management

Regulatory compliance

Quality Agreements

Cross-functional collaboration

Outils

eClinical platforms

CSV

Data integrity tools

Description du poste

Capgemini Engineering is seeking a Vendor Quality Specialist to support GCP vendor qualification, Quality Agreement lifecycle, and CAPA management within a regulated pharmaceutical environment. The role collaborates with Procurement, Legal and Quality Leads to ensure compliance with EMA, FDA and ICH guidelines, while driving process improvements and digital quality initiatives across vendor management.

The successful candidate brings strong GCP knowledge, extensive vendor oversight experience,