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.
Responsibilities
Support manufacturing sites and global networks in proactively identifying and closing 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.
Oversee 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.
Travel 10% of the time.
Qualifications
Bachelor's or Master’s Degree in Chemical Engineering, Biochemical Engineering, or Life Sciences with 10+ years of relevant industrial experience in parenteral production (compounding to Visual inspection) within quality systems, quality operations, or pharmaceutical manufacturing.
Strong knowledge of stability management across 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.
High degree of problem‑solving skills and the ability to gain alignment with internal stakeholders and authorities in operationally demanding environments. Collaborative leadership and clear guidance to matrix teams while maintaining focus on implementation, compliance, and reliability throughout the QMS lifecycle.
Roche is an Equal Opportunity Employer.
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Responsibilities
Support manufacturing sites and global networks in proactively identifying and closing 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.
Oversee 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.
Travel 10% of the time.
Qualifications
Bachelor's or Master’s Degree in Chemical Engineering, Biochemical Engineering, or Life Sciences with 10+ years of relevant industrial experience in parenteral production (compounding to Visual inspection) within quality systems, quality operations, or pharmaceutical manufacturing.
Strong knowledge of stability management across 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.
High degree of problem‑solving skills and the ability to gain alignment with internal stakeholders and authorities in operationally demanding environments. Collaborative leadership and clear guidance to matrix teams while maintaining focus on implementation, compliance, and reliability throughout the QMS lifecycle.
Roche is an Equal Opportunity Employer.
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Global MSAT Tech & Network Standards Steward Arbeitgeber: Roche
Roche bietet als Arbeitgeber eine inspirierende und innovative Arbeitsumgebung in Rotkreuz, wo Mitarbeiter in einem interdisziplinären Team an der Schnittstelle von Wissenschaft und Technologie arbeiten. Die Unternehmenskultur fördert Zusammenarbeit und persönliche Entwicklung, während umfassende Schulungs- und Weiterbildungsmöglichkeiten sowie flexible Arbeitsmodelle den Mitarbeitern helfen, ihre Karriereziele zu erreichen. Zudem engagiert sich Roche für Vielfalt und Chancengleichheit, was das Unternehmen zu einem attraktiven Arbeitsplatz für alle macht, die einen bedeutungsvollen Beitrag zur Gesundheitsversorgung leisten möchten.
