The Global MSAT Quality Systems (QMS) Specialist is a key global matrix role acting as the interface between Global MSAT / Engineering / Device, Packaging & Distribution MSAT (PTT) and the Quality Systems organization (PTQ). The position ensures that global quality processes are consistently applied, compliant, and efficiently executed across the Large Molecule Drug Product manufacturing network.
Within Pharma Technical Operations (PT), Pharma Technical Technology (PTT) is responsible for industrialization and technical product management, with a strong focus on robustness, operational efficiency, and sustainable manufacturing performance. The global Manufacturing Science and Technology (gMSAT) organization oversees commercial products, technology implementation, standardization initiatives, and proactive risk mitigation in close collaboration with cross‑functional stakeholders worldwide.
This role requires solid GMP expertise, strong organizational capabilities, and a proactive mindset to manage complex global quality system activities.
Candidate Profile
The ideal candidate holds a scientific degree in Pharmaceutical Sciences or a related discipline and brings at least three years of professional experience in Quality Systems within a GMP‑regulated environment. Experience supporting MSAT or Engineering organizations is highly valued. Proficiency in electronic document and learning management systems is essential. Fluent English communication skills are required; German language skills are considered an advantage.
General Information
* Start Date: 01 February 2026
* Contract Duration: 2 years (extension very likely)
* Remote Work: Limited to 1–2 days per week
* Travel: Approximately 10%
* Criminal Record Extract: Required
Key Responsibilities
* QMS Process Ownership: Manage the end-to-end lifecycle of changes to PTT-owned QMS documents, including change initiation, coordination of global action items, follow-up with responsible owners, and securing final approval prior to implementation
* Document and System Support: Provide operational support for Veeva Vault QualityDocs, oversee QMS document lifecycles, and maintain standardized templates
* Inspection and Audit Support: Coordinate, track, and ensure timely closure of PTT-related CAPAs resulting from health authority inspections and internal audits
* Training Coordination: Assign and manage training activities via Cornerstone and act as the interface between Global MSAT and the PTQ Learning organization
Must-Have Qualifications
* Bachelor’s, Master’s, or PhD degree, preferably in Pharmaceutical Sciences, Quality Management, or related fields
* Minimum of 3–5 years of experience in Quality Systems and GMP operations
* Proven hands‑on experience with Quality Management Systems, including Change Control and CAPA management
* Knowledge of MSAT (Manufacturing Science and Technology) or Engineering operations in a pharmaceutical environment
* Strong user‑level experience with electronic Document Management Systems and Learning Management Systems (e.g., Veeva Vault QualityDocs, Cornerstone)
* Collaborative leadership skills with experience in matrix organizations, strong communication, negotiation, and decision‑making abilities
* Fluent English; German language skills are a plus
Nice-to-Have Qualifications
* Experience in global or cross‑site roles supporting international teams
* Strong technical writing skills with the ability to translate complex technical topics into clear, compliant documentation
#J-18808-Ljbffr