Global MSAT Tech & Network Standards Steward — Roche
NouveauCHF 49 500 - 75 000
Roche · Basel (BS)
- Lieu
- Basel
- Contrat
- full-time
- Publié
- il y a 2 jours
SalaireCHF 49 500 - 75 000
Vue d’ensemble du poste
At Roche you can show up as yourself, embraced for the unique qualities you bring.
Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.
- At Roche you can show up as yourself, embraced for the unique qualities you bring.
- Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
- 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
Responsabilités principales
- 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
Détails supplémentaires
- 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:
Notes et contenu original
- 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:
