Descripción de la oferta
At Roche you can show up as yourself, embraced for the unique qualities you bring. The Position At Roche, where structure, innovation, and patient safety converge, we are committed to delivering high-quality healthcare solutions worldwide. As a GxP Supplier Quality Manager, you will play a pivotal role in maintaining the integrity of our global supply chain across the entire lifecycle of GxP suppliers (Source & Select, Implement, Manage, and Decommission). You will serve as a primary quality key contact for Contract Manufacturing Organizations (CMOs), and Contract Laboratory Organizations (CLOs), ensuring that external partnerships align with Roche's high quality standards and regulatory commitments. GxP Supplier Lifecycle Management: Oversee all required quality activities across the full lifecycle of assigned GxP suppliers (Source & Select, Implement, Manage, and Decommission), including process or method validations, Roche audits, Health Authority inspections, complex investigations, product complaints, and regulatory submissions.
Quality Agreements: Develop, negotiate, and maintain Quality Agreements with GxP suppliers, Partners, Collaborators, and External Sponsors, ensuring continuous compliance with agreed terms and regulations.
Supplier Collaboration & Escalation: Collaborate with GxP suppliers to address gaps in audit responsiveness, deviation reporting/management, CAPA implementation, complaint resolution, investigation closures, and change control timelines; escalatie quality or compliance risks appropriately.
Support "Make Assess": Manage all required quality deliverables supporting the Make Assess phase of Roche products, including approval of master process documentation, batch documentation review, resolution of complex deviations, change assessment, and ongoing supplier quality performance monitoring.
Ensure manufacturing and QC processes (including Specifications, Analytical Methods, and stability testing programs) remain in a validated state and fully compliant with applicable regulatory dossiers.
Quality Risk Management (QRM): Develop and maintain quality risk management plans using established QRM tools (e.g., FMEA, root cause analysis) to proactively identify, mitigate, and monitor supplier quality and compliance risks.
Technical Transfers & Product Launches: Lead and execute quality deliverables supporting technical transfers for manufacturing, testing, packaging, and commercial product launches at external sites.
Continuous Improvement & Operational Excellence: Engage in cross-functional continuous improvement initiatives to solve complex manufacturing or quality challenges while driving alignment between supplier operations and Roche strategic goals.
Regulatory Landscape & Intelligence: Communicate updated regulatory requirements and Roche expectations to GxP suppliers, evaluating site quality systems for ongoing compliance.
You are a self-motivated Quality professional who thrives in a dynamic, matrixed environment. Experience: Minimum of 3–5 years of progressive experience in the pharmaceutical or biotech industry in Quality Assurance, Quality Control, or Supplier Quality Management.
Influence & Stakeholder Management: Strong capability to interpret complex quality standards, drive accountability with external vendors without direct authority, and negotiate Quality Agreements.
Technical Skills: Operational Excellence (Lean/Six Sigma) and Project Management experience are a plus.
High proficiency in MS Office or Google Workspace applications (Excel, PowerPoint, Word, Project).
Excellent written and verbal communication skills in English (fluency is required). Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. We believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We are many, working as one across functions, across companies, and across the world.
