Global MSAT Quality Systems (QMS) Specialist
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, housing vital research and development functions. We are currently seeking a Global MSAT Quality Systems (QMS) Specialist for our esteemed client, F. Hoffmann-La Roche AG, located in Basel.
Background:
The Global MSAT Quality Systems (QMS) Specialist is a crucial role that serves as the primary link between the Pharma Technical Team (PTT) — including Global MSAT, Engineering, Device, Packaging, and Distribution MSAT — and the Quality Systems (PTQ) team. This specialist plays a key role in ensuring the efficient and compliant execution of global quality processes by managing QMS documentation, training, and corrective actions, thus maintaining regulatory excellence across the large molecule drug product network.
Within Pharma Technical Operations (PT), the Pharma Technical Technology (PTT) division focuses on the industrialization and technical management of products, emphasizing robustness, efficiency, and reliability across the manufacturing network. The global Manufacturing Science and Technology (gMSAT) department governs commercial products, overseeing the drug substance and product network, technology implementation, standardization, and risk mitigation. gMSAT operates within cross-functional squads organized by Large and Small Molecule, Technology and Network Standards, and Operations. This role necessitates a solid understanding of GMP environments, exceptional organizational skills, and a proactive approach to managing complex global quality processes.
Tasks & Responsibilities:
- QMS Process Management: Oversee the complete lifecycle of changes for PTT-owned QMS documents. This includes managing change initiation, assigning action items to responsible owners across the global network, ensuring timely completion, and securing the final "approval to execute" before documentation is made effective.
- Document & System Support: Provide operational support for Veeva Vault QualityDocs, manage the lifecycle of QMS documents, and maintain standardized templates.
- Inspection & Audit Support: Coordinate and track PTT-owned CAPAs from Health Authority inspections and audits, ensuring timely closure of all commitments.
- Training Coordination: Manage training assignments via Cornerstone and act as the liaison between Global MSAT and the PTQ Learning Team.
Must Haves:
- BS/MS/PhD degree (preferably in Pharmaceutical Science or related fields in Quality Systems).
- 3-5 years of experience in Quality Systems and GMP operations.
- Demonstrated experience with Quality Management Systems (QMS), particularly CAPA management and Change Control.
- Knowledge of Manufacturing Science and Technology (MSAT) or Engineering operations in a pharmaceutical setting.
- Proficient in electronic Document Management Systems (e.g., Veeva Vault QualityDocs) and Learning Management Systems.
- Leadership capabilities with collaborative and matrix team leadership experience. Strong communication and negotiation skills are essential for establishing trustworthy and successful relationships.
- Fluent in English; German language skills are a plus.
Nice to Have:
- Experience in a global role or supporting global teams.
- Proven technical writing skills with the ability to translate complex technical information into clear, compliant documentation.
What You Will Be Offered:
- An opportunity to work with one of the world's leading pharmaceutical companies.
- A modern campus featuring ample green spaces and collaborative meeting areas.
- Central location in Basel.
- Remote work options are available.
- A varied job profile.
- Further training opportunities through temptraining.
- The chance to work within a dynamic and motivated team.
If you are interested, please apply online using the form below. Only applications matching the job profile will be considered.