Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.
La position As 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 Opportunity In 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 are You 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 7 + 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.
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel.
Roche est un employeur offrant l'équité en matière d'emploi.
#J-18808-Ljbffr
La position As 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 Opportunity In 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 are You 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 7 + 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.
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel.
Roche est un employeur offrant l'équité en matière d'emploi.
#J-18808-Ljbffr
Global MSAT Tech & Network Standards Steward Arbeitgeber: Roche Holding AG
Roche Holding AG ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Basel eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf persönliche und berufliche Weiterentwicklung sowie einer Kultur der Zusammenarbeit und Innovation, ermöglicht Roche seinen Mitarbeitern, bedeutende Beiträge zur Qualitätssicherung in der Herstellung zu leisten. Die Möglichkeit, an Transformationsprozessen mitzuwirken und Einfluss auf strategische Entscheidungen zu nehmen, macht diese Position besonders attraktiv für engagierte Fachkräfte.
