Vendor Quality Specialist | Life Sciences

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.