Global MSAT Quality Systems (QMS) Specialist (m/f/d) : Quality Systems/ GMP Operations/ QMS/ CAPA/ Change Control/ MSAT/ Engineering Operations/ Pharma/ Veeva Vault/ Quality Docs/ LMS/ English
Project:
For our pharmaceutical customer based in Basel, we are looking for a Global MSAT Quality Systems (QMS) Specialist (m/f/d)
Background:
The Global MSAT Quality Systems (QMS) Specialist is a pivotal matrix role, serving as the critical link between PTT (Global MSAT/Engineering/ Device, Packaging and Distribution MSAT) and the Quality Systems (PTQ) team. This specialist ensures the compliant and efficient execution of global quality processes-driving QMS documentation, training, and corrective actions, to maintain regulatory excellence across the large molecule drug product network.
As part of Pharma Technical Operations (PT), Pharma Technical Technology (PTT) drives industrialization and technical product management, focusing on robustness, efficiency, and reliability across the manufacturing network. Within PTT, the global Manufacturing Science and Technology (gMSAT) department owns commercial products, overseeing the drug substance and product network, technology implementation, standardization, and risk mitigation. gMSAT operates in cross-functional squads organized by Large/Small Molecule, Technology and Network Standards, and Operations. This role requires a strong understanding of GMP environments, excellent organizational skills, and a proactive approach to managing complex global quality processes.
The Perfect Candidate possesses a degree in Pharmaceutical Science and over three years of experience in Quality Systems and GMP operations. Essential knowledge includes MSAT, proficiency with electronic Document Management Systems, and fluent English communication skills.
Tasks & Responsibilities:
* QMS Process Management: Oversee the full lifecycle of changes for PTT owned QMS documents, from change initiation and action item assignment to responsible owners across the global network, driving completion and secure 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 the 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 Quality System related fields)
* Min. 3-5 years of experience in Quality Systems and GMP operations
* Demonstrated experience with Quality Management Systems (QMS), specifically CAPA management and Change Control
* Knowledge of MSAT (Manufacturing Science and Technology) or Engineering operations in a pharma setting
* Proficiency with electronic Document Management Systems (e.g., Veeva Vault QualityDocs) and Learning Management Systems
* Leadership: collaborative, matrix team leadership experience and decision-making skills. Network mindset as well as strong communication and negotiation skills enabling you to establish trustful and successful relationships.
* English fluent, German is a plus
Nice to have :
* Experience in a global role or supporting global teams.
* Proven technical writing skills with an ability to translate complex technical information into clear, compliant documentation