## Global MSAT Tech & Network Standards StewardCandidatar-selocations:
Basel:
Mannheim:
Hillsborotime type:
Tempo integralposted on:
Publicado hojetime left to apply:
Data de término: 17 de julho de 2026 (9 dias restantes para se candidatar)job requisition id:
202607-117620Na Roche, você pode-se apresentar como você mesmo, abraçado pelas qualidades únicas que traz. Nossa cultura incentiva a expressão pessoal, o diálogo aberto e as conexões genuínas, onde você é valorizado e respeitado por quem você é, e permitindo que você prospere tanto pessoal como profissionalmente. É assim que pretendemos prevenir, deter e curar doenças e garantir que todos tenham acesso aos cuidados de saúde hoje e nas gerações futuras. Junte-se à Roche, onde cada voz é importante.### A posiçãoAs an integral part of Pharma Technical Operations (PT), PT Global MSAT, Engineering and Sustainability (PTT) plays a key role in leading a seamless industrialization and thorough technical product management through integrating SHE, proactive maintenance, facility fitness, performance optimization and scalable manufacturing processes and technologies in support of the manufacturing network. Product and process robustness, efficiency and reliability are key performance indicators, PTT owns and drives continuous improvement.
We are looking for a technical expert who understands the realities of the manufacturing areas and can design standard operating frameworks that drive operational excellence and compliance.### The OpportunityIn this role you proactively identify and close quality systems gaps across the network and you serve as translator between shop-floor manufacturing realities and global quality standards, ensuring that compliance frameworks enable manufacturing throughput and continuous improvement.More responsibilities include:* Support manufacturing sites and global networks in proactively identifying and close quality systems gaps, implementing standardized processes and quality standards* Drive the delivery and sustainment of a robust and regulatory-compliant Quality Management System (QMS) process as global single point of contact and core decision-maker for the assigned global quality system process content and design* Translate HA requirements into an implementable QMS process, collaborating closely with independent quality compliance partners, staying updated on evolving regulations, health authority expectations, and external industry benchmarks to drive continuous optimization of the Quality Management System (QMS)* Oversees the timely execution of critical deliverables, including global policy updates, IT/digital tool enhancements (e.g., Veeva), training deployment, and performance metric tracking for the assigned global quality system process .* Provide expert guidance and direct support for regulatory inspections and health authority audits relating to global quality system processes.* Manage intersections with other quality system process owners to achieve seamless, end-to-end process management across cross-functional squads and technical governance forums.### Who you areYou are a specialized expert in manufacturing technologies and compliance with a strong sense of accountability and exceptional strategic decision-making capabilities. Your qualifications include:* Bachelor's or Master’s Degree in Chemical Engineering, Biochemical Engineering, or the Life Science with 10+ years or more of relevant industrial experience in parenteral production (compounding to Visual inspection) within quality systems, quality operations, or pharmaceutical manufacturing.* Strong Knowledge in stability management through out distribution is a plus* Specialized knowledge of pharmaceutical quality systems and industry-wide guidelines relevant to pharma process development and manufacturing, such as ICH guidelines.* Strong digital acumen and experience supporting IT-solutions or quality management platforms, such as Veeva, is highly preferred.* High degree of problem-solving skills and the ability to gain alignment with internal stakeholders and authorities in operationally demanding environments. You are a collaborative leader who excels in providing clear guidance to matrix teams while maintaining a focus on implementation, compliance, and reliability through the QMS process lifecycle<10% travel requiredReady to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity! #J-18808-Ljbffr
Basel:
Mannheim:
Hillsborotime type:
Tempo integralposted on:
Publicado hojetime left to apply:
Data de término: 17 de julho de 2026 (9 dias restantes para se candidatar)job requisition id:
202607-117620Na Roche, você pode-se apresentar como você mesmo, abraçado pelas qualidades únicas que traz. Nossa cultura incentiva a expressão pessoal, o diálogo aberto e as conexões genuínas, onde você é valorizado e respeitado por quem você é, e permitindo que você prospere tanto pessoal como profissionalmente. É assim que pretendemos prevenir, deter e curar doenças e garantir que todos tenham acesso aos cuidados de saúde hoje e nas gerações futuras. Junte-se à Roche, onde cada voz é importante.### A posiçãoAs an integral part of Pharma Technical Operations (PT), PT Global MSAT, Engineering and Sustainability (PTT) plays a key role in leading a seamless industrialization and thorough technical product management through integrating SHE, proactive maintenance, facility fitness, performance optimization and scalable manufacturing processes and technologies in support of the manufacturing network. Product and process robustness, efficiency and reliability are key performance indicators, PTT owns and drives continuous improvement.
We are looking for a technical expert who understands the realities of the manufacturing areas and can design standard operating frameworks that drive operational excellence and compliance.### The OpportunityIn this role you proactively identify and close quality systems gaps across the network and you serve as translator between shop-floor manufacturing realities and global quality standards, ensuring that compliance frameworks enable manufacturing throughput and continuous improvement.More responsibilities include:* Support manufacturing sites and global networks in proactively identifying and close quality systems gaps, implementing standardized processes and quality standards* Drive the delivery and sustainment of a robust and regulatory-compliant Quality Management System (QMS) process as global single point of contact and core decision-maker for the assigned global quality system process content and design* Translate HA requirements into an implementable QMS process, collaborating closely with independent quality compliance partners, staying updated on evolving regulations, health authority expectations, and external industry benchmarks to drive continuous optimization of the Quality Management System (QMS)* Oversees the timely execution of critical deliverables, including global policy updates, IT/digital tool enhancements (e.g., Veeva), training deployment, and performance metric tracking for the assigned global quality system process .* Provide expert guidance and direct support for regulatory inspections and health authority audits relating to global quality system processes.* Manage intersections with other quality system process owners to achieve seamless, end-to-end process management across cross-functional squads and technical governance forums.### Who you areYou are a specialized expert in manufacturing technologies and compliance with a strong sense of accountability and exceptional strategic decision-making capabilities. Your qualifications include:* Bachelor's or Master’s Degree in Chemical Engineering, Biochemical Engineering, or the Life Science with 10+ years or more of relevant industrial experience in parenteral production (compounding to Visual inspection) within quality systems, quality operations, or pharmaceutical manufacturing.* Strong Knowledge in stability management through out distribution is a plus* Specialized knowledge of pharmaceutical quality systems and industry-wide guidelines relevant to pharma process development and manufacturing, such as ICH guidelines.* Strong digital acumen and experience supporting IT-solutions or quality management platforms, such as Veeva, is highly preferred.* High degree of problem-solving skills and the ability to gain alignment with internal stakeholders and authorities in operationally demanding environments. You are a collaborative leader who excels in providing clear guidance to matrix teams while maintaining a focus on implementation, compliance, and reliability through the QMS process lifecycle<10% travel requiredReady to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity! #J-18808-Ljbffr
Global MSAT Tech & Network Standards Steward Arbeitgeber: F. Hoffmann-La Roche AG
F. Hoffmann-La Roche AG bietet eine herausragende Arbeitsumgebung in Basel, die von Innovation und Zusammenarbeit geprägt ist. Als Arbeitgeber im biopharmazeutischen Sektor fördern wir das Wachstum unserer Mitarbeiter durch kontinuierliche Weiterbildung und Entwicklungsmöglichkeiten. Unsere Unternehmenskultur legt Wert auf Vielfalt und Teamarbeit, was es zu einem idealen Ort macht, um bedeutende Beiträge zur Zukunft der Gesundheitsversorgung zu leisten.
