Vendor Quality Lead H/F/X

Beschrijving van de functie

Contracting - Brabant Wallon

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. 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.

Jouw profiel

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. Nice to have 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).

Taalvaardigheden

• Frans (troef)

  • Begrijpen : Vaardig - (C1)
  • Schrijven : Vaardig - (C1)
  • Lezen : Vaardig - (C1)
  • Spreken : Vaardig - (C1)

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