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

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s mostinnovative companies unleash their potential. From autonomous cars to life‑saving robots, our digital and software technology experts think outside the box as theyprovide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days arethe same.

Your Role

As a Vendor Quality Specialist, you will support the quality oversight framework applied to clinical trial vendors and service providers within a growing R&D & Pharmacovigilance Vendor Quality Team. Working closely with senior quality team members and cross-functional stakeholders, you will take ownership of vendor qualification activities, Quality Agreement lifecycle management, and GCP compliance support in a highly regulated pharmaceutical environment.

In this role you will play a key role in:

• Supporting GCP vendor qualification and risk-based assessment activities, participating in compliance monitoring, performance tracking, governance meeting preparation, and issue escalation and follow-up for assigned vendors.
• Managing Quality Agreements throughout their full lifecycle — from creation and setup through review, revision, and closure — collaborating with Procurement, Legal, Quality Leads and business stakeholders to ensure timely execution and help reduce the existing backlog.
• Acting as a quality support contact for vendor‑related deviations, investigations, audit observations, and compliance issues, supporting CAPA implementation and contributing to inspection readiness initiatives.
• Ensuring all vendor oversight activities remain compliant with GCP requirements and applicable regulatory expectations from the EMA, FDA, and ICH guidelines, while contributing to continuous improvement and harmonization projects across the Vendor Quality framework.
• Supporting digitalization and process optimization initiatives within the Quality organization, leveraging modern IT and digital quality systems to drive efficiency and compliance across vendor management activities.

Your Profile

We’re looking for an experienced, autonomous quality professional with a strong GCP background and a collaborative mindset. You bring proven expertise in vendor quality management and are comfortable navigating complex regulatory environments while managing multiple priorities with precision.

• GCP and clinical quality expertise with a minimum of 5 years of relevant experience in GCP Quality, Clinical Operations, Clinical Vendor Management, or Quality Assurance, with a strong understanding of clinical trial processes, risk-based vendor oversight principles, and deviation and CAPA management.
• Quality Agreement proficiency, with hands‑on experience drafting, reviewing, updating, and maintaining Quality Agreements, and a solid understanding of quality governance frameworks between sponsors and external vendors in a regulated clinical setting.
• Regulatory knowledge of ICH guidelines, EMA requirements, and FDA regulations, with the ability to practically apply these frameworks to vendor oversight activities and inspection readiness preparation.
• Systems and digital proficiency, with comfort working in digital quality systems and modern IT tools; experience with eClinical platforms, CSV, or data integrity initiatives is a strong advantage.
• Strong communication and organizational skills, with the ability to work independently while collaborating effectively with senior SMEs and a wide range of internal and external stakeholders, bringing a structured, detail‑oriented, and learning‑focused mindset to every task.

What You’ll Love About Working Here

• Own your Growth: Free access for all to world‑class learning assets and curated programs from Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, Google and many more. Our engineering academy offers more than 60,000 hours of training to support your professional development.
• Connect for Success: Our professional communities foster career development and strengthen Capgemini's capabilities across various domains. You will also benefit from mentoring programs to stimulate your professional growth.
• Lead the Change: As a global leader in engineering services, Capgemini Engineering combines its broad industry knowledge and cutting‑edge technologies to help our clients develop the smart products and services of tomorrow.

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end‑to‑end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.