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Global msat quality systems (qms) specialist

Basel
Festanstellung
ITech Consult
Inserat online seit: 14 Januar
Beschreibung

Global MSAT Quality Systems (QMS) Specialist

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 pharmaceutical setting
* Proficiency with electronic Document Management Systems (eg, 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

Reference No.: 924666
Role: Global MSAT Quality Systems (QMS) Specialist (m/f/d)
Industry: Pharma
Place of work: Basel/Kaiseraugst
Workload: 100%
Start: February 1st, 2026
Duration: 2 Years
Application deadline: January 13th, 2026

If this position has sparked your interest, please send us your complete application via the link in this advertisement. If this position is not a good fit for your profile and you would like to receive information about other positions directly, you can also send us your application via this advertisement or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive payroll-only program: +41 41 760 77 01.

About Us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing IT candidates for contract work. Founded in 1997 by IT professionals, we understand the importance of professional support in project searches and work.

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