Descripción de la oferta
Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die 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.
Key Responsibilities & Main Tasks
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; elevate 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.
Validated State & Compliance Maintenance: 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.
Who You Are
You are a self-motivated Quality professional who thrives in a dynamic, matrixed environment. You bring strong critical thinking, proactive communication, and the ability to influence external partners while keeping patient safety at the center of every decision.
Qualifications & Experience:
Education: Ideally, a B.A. or B.S. degree in Life Sciences, Chemistry, Pharmacy, Engineering, or a related discipline (or equivalent combination of education and industry experience).
Experience: Minimum of 3–5 years of progressive experience in the pharmaceutical or biotech industry in Quality Assurance, Quality Control, or Supplier Quality Management.
GxP & Supplier Expertise: Demonstrated experience with GxP supplier oversight (e.g., CMOs, CLOs, direct material suppliers) and familiarity with different technology platforms/dosage forms is preferred.
Regulatory Knowledge: Sound knowledge of cGMP, ISO standards, and international pharmaceutical regulations (e.g., FDA, EMA, ICH Q9/Q10/Q12).
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).
Languages & Travel: Excellent written and verbal communication skills in English (fluency is required). Ability to travel domestically and/or internationally up to 10%.
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
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