Work Selection AG
As a first-tier supplier to our renowned business partner F. Hoffmann-La Roche Ltd. in Basel, we are currently looking for a motivated and dedicated Global MSAT Quality Systems (QMS) Specialist for a temporary assignment of 12 months. 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. 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, operating in cross‑functional squads organized by Large/Small Molecule, Technology and Network Standards, and Operations.
Tasks
* 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; drive completion and secure the final "approval to execute" before documentation is 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 liaison between Global MSAT and the PTQ Learning Team.
Must Haves
* BS/MS/PhD degree (preferably in Pharmaceutical Science or Quality System related fields).
* Minimum 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 and strong communication and negotiation skills enabling trustful and successful relationships.
* English fluent; German is a plus.
Nice to Haves
* 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.
Benefits
* Work with modern and up‑to‑date tools in an innovative work environment.
* Experience a work culture that promotes diversity and inclusion where all employees feel valued.
* Benefit from financial support for your professional development plans.
* Take advantage of unbeatable, year‑round discounts at renowned retailers and over 200 top brands.
* Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card.
* Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare.
* Work on a state‑of‑the‑art campus featuring green spaces, meeting areas, and an inspiring atmosphere.
* Take advantage of attractive fitness and swimming pool facilities or the gaming room as a creative retreat.
* Enjoy a selection of high‑quality meals in modern staff restaurants.
* As part of a sustainable mobility concept, on-site parking spaces are available to you, provided you meet the relevant qualifications.
* Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days.
Are you interested? Don’t hesitate and submit your complete application documents online today. We look forward to hearing from you!
Wir wertschätzen Vielfalt und begrüßen daher alle Bewerbungen unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender‑Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.
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