Overview A Vendor Quality Lead is being sought to strengthen the R&D & Pharmacovigilance Vendor Quality team.
This role will support GCP-focused vendor qualification activities, quality agreement setup, and vendor oversight, particularly due to a backlog of agreements and an increasing number of GCP vendors.
Team Information The team is part of R&D and Pharmacovigilance Vendor Quality within the global Quality organization.
The team covers GLP, GCP, and GVP, but this position will focus primarily on GCP
Typical Day Managing GCP vendor qualification activities .
Handling the setup, review, update, and closure of Quality Agreements (priority focus).
Supporting risk-based vendor oversight : governance meetings, issue escalation, documentation follow-up.
Acting as the QA point of contact for deviations, investigations, and audit observations related to assigned vendors.
Ensuring inspection readiness and compliance with GCP and EMA/FDA/ICH requirements .
Collaborating with internal stakeholders: Quality Leads, Global QA, Procurement, Legal, IT/CSV.
Interacting directly with vendor organizations regarding performance, compliance, and governance .
Driving continuous improvement and contributing to harmonization initiatives .
Requirements Minimum 10 years of relevant experience .
Strong seniority is required; candidates with only 5–6 years of experience will not meet the expected level of expertise .
Must-Have Skills Strong GCP background and understanding of clinical trial management.
Proven experience in vendor qualification and vendor management .
Solid experience in Quality Agreements lifecycle management .
Knowledge of regulatory requirements (EMA/FDA/ICH).
Experience with risk-based oversight and CAPA lifecycle .
Fluent in English (mandatory).
Comfortable with digital tools and technological processes .
Strong professional judgment, ability to act independently, and manage complex situations.
Nice-to-Have Skills French language skills (not mandatory; English is the working language).
Experience with Digital/IT systems, data integrity, IT validation, eClinical tools.
Legal or paralegal background (advantageous for Quality Agreements).
Experience with AI-driven or digitalization initiatives .
Vendor management experience in additional GxP areas (excluding GMP/GDP profiles).
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