Global MSAT Quality Systems (QMS) Specialist
Contract Duration: 1 year (extension likely)
Start Date: 01.02.2026
Workload: 100% | Hybrid: up to 1–2 home office days/week
About the Role
The Global MSAT Quality Systems (QMS) Specialist plays a key matrix role connecting PTT (Global MSAT/Engineering/Device, Packaging & Distribution MSAT) with PTQ Quality Systems. You will ensure compliant, seamless execution of global quality processes—owning QMS documentation workflows, training coordination, and CAPA follow‑up across the large‑molecule drug product network.
Pharma Technical Technology (PTT) drives industrialization and technical product management within Pharma Technical Operations (PT), ensuring robustness, efficiency, and reliability across the global manufacturing footprint. As part of this, the global MSAT (gMSAT) department manages commercial products end‑to‑end, overseeing technology implementation, standardization, and network excellence.
This role is ideal for a proactive Quality Systems professional with strong GMP experience and a passion for cross‑functional coordination in a global environment.
Key Responsibilities
Quality Systems (QMS) Process Management
* Own and manage the end‑to‑end lifecycle of PTT QMS documents
* Initiate changes, define action items, and coordinate with responsible owners across the global network
* Drive timely completion and ensure “approval to execute” before documents go live
Document & System Support
* Provide operational support for Veeva Vault QualityDocs
* Manage the lifecycle of QMS documentation and maintain aligned templates and standards
Inspection & Audit Support
* Coordinate and track PTT‑owned CAPAs from Health Authority inspections and audits
* Ensure commitments are addressed and closed on time
Training Coordination
* Manage training assignments via Cornerstone
* Act as the key interface between Global MSAT and the PTQ Learning Team
Required Qualifications
Education
* BS/MS/PhD—preferably in Pharmaceutical Science or a related Quality Systems field
Experience & Technical Skills
* 3–5+ years of experience in Quality Systems and GMP operations
* Proven expertise in QMS, especially CAPA management and Change Control
* Knowledge of MSAT (Manufacturing Science & Technology) or pharma/engineering operations
* Hands‑on experience with:
* Electronic Document Management Systems (e.g., Veeva Vault QualityDocs)
* Learning Management Systems (e.g., Cornerstone)
Soft Skills
* Strong communicator with excellent negotiation and stakeholder management abilities
* Effective in matrix environments; able to influence without authority
* Organized, detail‑oriented, and proactive in managing complex global processes
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