Experteer Overview Join Roche as a GxP Supplier Quality Manager and help safeguard our global supply chain. You’ll serve as the quality lead for CMOs and CLOs, ensuring alignment with Roche standards and regulatory commitments. You’ll oversee the full supplier lifecycle, drive quality agreements, and support transfers and product launches. Your work enables high-quality healthcare solutions and patient safety at scale, in a collaborative, matrixed environment. Compensaciones / Ventajas
• Oversee GxP supplier lifecycle across Source u0026 Select, Implement, Manage, and Decommission
• Develop and maintain Quality Agreements with suppliers and partners
• Collaborate with suppliers to address audit gaps, deviation management, CAPA, and change control timelines; escalate risks
• Support Make Assess phase including master process documentation approvals and batch documentation reviews
• Ensure processes remain validated and compliant with regulatory dossiers
• Develop and maintain Quality Risk Management plans using QRM tools (e.g., FMEA)
• Lead quality deliverables for technical transfers and product launches at external sites




• Drive continuous improvement initiatives to align supplier operations with Roche goals
• Communicate regulatory updates to suppliers and assess site quality systems for compliance Responsabilidades
• Minimum 3–5 years in pharmaceutical/biotech Quality Assurance, Quality Control, or Supplier Quality Management
• GxP supplier oversight experience with CMOs/CLOs and various dosage forms
• Knowledge of cGMP, ISO standards, FDA/EMA/ICH Q9/Q10/Q12
• Ability to interpret complex quality standards and negotiate Quality Agreements
• Strong stakeholder management and external collaboration skills
• Project management and Lean/Six Sigma familiarity (a plus)
• Proficiency in MS Office or Google Workspace
• Fluent English; willing to travel up to 10%
• Educational background in Life Sciences, Chemistry, Pharmacy, Engineering, or related field
• Experience with regulatory inspections or health authority interactions (preferred) Requisitos principales •

📌 GxP Supplier Quality Manager (Madrid)
🏢 Roche
📍 Madrid