Vendor Quality Specialist (GCP)

Our client, a leading biopharmaceutical organization, is seeking a Vendor Quality Specialist to join their R&D and Pharmacovigilance team. This role focuses on supporting GCP-focused vendor qualification activities and managing the lifecycle of quality agreements to ensure robust vendor oversight and compliance.

• Support GCP vendor qualification activities and manage the lifecycle of quality agreements from setup to closure.
• Participate in risk-based vendor oversight by following up on documentation, tracking issues, and preparing for governance meetings.
• Act as a QA support contact for deviations, investigations, and audit observations related to assigned vendors.
• Ensure inspection readiness and adherence to GCP and regulatory expectations from the EMA, FDA, and ICH.
• Collaborate with cross-functional stakeholders including procurement, legal, and IT to manage vendor performance.
• Contribute to continuous improvement and harmonization initiatives across the vendor quality framework.

• You have 5+ years of relevant experience in GCP, clinical operations, or vendor management within a QA environment.
• You possess practical experience with vendor qualification and managing the Quality Agreement lifecycle.
• You bring a solid understanding of regulatory requirements including EMA, FDA, and ICH guidelines.
• You have experience with risk-based oversight and familiarity with CAPA processes.
• You're comfortable working with digital tools and modern Quality/IT systems.
• You demonstrate good professional judgment and a proactive willingness to learn while working with moderate supervision.
• You are fluent in English.

Nice to Haves

• Experience with CSV, data integrity, or eClinical tools.
• Exposure to AI-driven digitalization initiatives or legal experience related to contracts.
• Vendor quality experience in additional GxP areas.

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