GCP Vendor Quality Specialist – Life Sciences

Capgemini Engineering; Diegem; Sur place; EUR 66 000 - 90 000; Plein temps

Avantages offerts par ce poste

Learning assets access

Mentoring programs

Global leader in engineering services

Résumé du poste

Capgemini Engineering is seeking a Vendor Quality Specialist to support GCP oversight of clinical trial vendors within a regulated R&D environment. You will own vendor qualification activities, manage Quality Agreements lifecycle, and ensure GCP compliance with cross‑functional teams.

We expect at least 5 years in GCP quality or vendor management, with strong regulatory knowledge and proficiency in digital quality systems.

Qualifications

• Minimum 5 years in GCP Quality, Clinical Vendor Management or QA.
• Experience drafting, reviewing and maintaining Quality Agreements.
• Solid regulatory knowledge of EMA, FDA and ICH guidelines.
• Proficient with digital quality systems and eClinical platforms.
• Strong communication and stakeholder management skills.

Responsabilités

• Support GCP vendor qualification and risk-based assessment activities.
• Manage Quality Agreements lifecycle with Procurement, Legal and SMEs.
• Act as quality contact for deviations, investigations, CAPA and audits.
• Ensure vendor oversight aligns with GCP, EMA, FDA and ICH guidelines.
• Support digitalization and process optimization within Quality.

Connaissances

GCP expertise

Quality governance

Quality agreements

Regulatory knowledge

Digital quality systems

Communication skills

Outils

eClinical platforms

CSV / data integrity

Description du poste

Capgemini Engineering is seeking a Vendor Quality Specialist to support GCP oversight of clinical trial vendors within a regulated R&D environment. You will own vendor qualification activities, manage Quality Agreements lifecycle, and ensure GCP compliance with cross‑functional teams.

We expect at least 5 years in GCP quality or vendor management, with strong regulatory knowledge and proficiency in digital quality systems.