Contracting - Brabant Wallon
Vendor Quality Lead
Description de la fonction
We are looking for a Vendor Quality Lead to reinforce the R&D & Pharmacovigilance Vendor Quality team.
The role is needed to support GCP-focused vendor qualification activities, quality agreements setup, and vendor oversight, especially due to a current backlog of agreements and increasing number of GCP vendors.
The role is needed to support GCP-focused vendor qualification activities, quality agreements setup, and vendor oversight, especially due to a current backlog of agreements and increasing number of GCP vendors.
- Managing GCP vendor qualification activities.
- Handling the setup, review, update and closure of Quality Agreements (priority scope).
- Supporting risk-based vendor oversight: governance meetings, issue escalation, documentation follow-up.
- Acting as QA point of contact for deviations, investigations, audit observations related to assigned vendors.
- Ensuring inspection readiness and compliance with GCP, EMA/FDA/ICH expectations.
- Collaborating with internal stakeholders (Quality Leads, Global QA, Procurement, Legal, IT/CSV).
- Interacting directly with vendor organizations for performance, compliance and governance.
- Driving continuous improvement and contributing to harmonization initiatives.
Profil
- Minimum 10 years of relevant experience.
- Strong seniority is required: candidates with 5–6 years of experience will not meet the expected level of expertise.
- Strong GCP background clinical trial management understanding.
- Proven experience in vendor qualification / 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 English & French.
- Ability to work with digital tools and comfortable with technological processes.
- Strong professional judgment, ability to act independently and manage complex situations.
- Experience with Digital/IT systems, data integrity, IT validation, eClinical tools.
- Legal/paralegal background is an asset for Quality Agreement work.
- Experience with AI-driven or digitalization initiatives.
- Vendor management experience in additional GxP areas (but not GMP/GDP profiles).
Offre
- Voiture d'entreprise
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, Afficher l'adresse e-mail