Manager QA - CMT 100% (m/f/d)

Description du poste Manager QA - CMT 100% (m/f/d) à Bubendorf

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<p>
Bachem, entreprise spécialisée en chimie peptidique, offre un poste de Manager QA.
Rejoignez un environnement dynamique avec des opportunités de développement.</p>
<h2>
Tâches</h2>
<ul>
<li>
Agir comme moteur d'innovation pour un produit commercial.</li>
<li>
Assurer une exécution '
Right First Time' des lots.</li>
<li>
Soutenir la planification et l'analyse pour maintenir les temps de cycle.</li>
</ul>
<h2>
Compétences</h2>
<ul>
<li>
Diplôme en chimie, génie chimique ou domaine connexe requis.</li>
<li>
Connaissance des GMP et des principes CMC essentielle.</li>
<li>
Compétences en communication et gestion de projet requises.</li>
</ul>
</div><div> <div> <p>
Bachem ist ein börsenkotiertes, auf die Peptid-Chemie fokussiertes Technologie-Unternehmen mit einem umfassenden Leistungsangebot für die Pharma- und Biotechnologie-Industrie.
Bachem ist spezialisiert auf die Entwicklung innovativer, effizienter Herstellungsverfahren und die zuverlässige Produktion Peptid-basierter pharmazeutischer Wirkstoffe.
Ein umfangreicher Katalog von Biochemikalien für Forschungszwecke und exklusive Kundensynthesen ergänzen das Angebot.
Mit Hauptsitz in der Schweiz sowie Niederlassungen in Europa und den USA ist das Unternehmen weltweit tätig und verfügt über die industrieweit grösste Erfahrung und Fachkompetenz.
In der Zusammenarbeit mit ihren Kunden legt Bachem grössten Wert auf Qualität, Innovation und Partnerschaft.</p> <h1>
Manager QA - CMT 100% (m/f/d)</h1> <div> <p>
The Commercial Manufacturing Team (CMT) Member works within a cross-functional team consisting of Manufacturing, Quality Assurance, and Quality Control.
The project execution is jointly accountable to the CMT Leader.
The position focuses on supporting products that have moved from development into the commercial manufacturing phase.</p> <p> <strong>
Your tasks:</strong> </p> <ul> <li>
Act as caretaker and process innovation driver for a commercial product.</li> <li>
Ensure "
Right First Time" execution and timely delivery of batches to downstream stakeholders.</li> <li>
Support the CMT Leader with planning, production oversight, and analysis to maintain required cycle times and QA processing times.</li> <li>
Learn and monitor material and information flows to support efficient commercial product cycles.</li> <li>
Participate in daily huddles</li> <li>
Monitor key process data to ensure manufacturing remains in a controlled state.</li> <li>
Drive process improvements, revalidations, and change implementations.</li> <li>
Communicate deviations and delays, and support cross-functional investigations to ensure timely closure and avoid delivery impacts.<br> <br> </li> </ul> <p> <strong>
Your profile:</strong> </p> <ul> <li>
Bachelor's / Masters degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field</li> <li>1-3 years of relevant biotech/pharma/CMO experience; 2 years in QA preferred</li> <li>
Strong knowledge of GMP, regulatory guidance (ICH, CFR), and CMC principles</li> <li>
Excellent German (min.
C1) and English (min.
C1) skills are mandatory</li> <li>
Experience with cross-functional team coordination</li> <li>
Skills in data analysis tools ERP (SAP), LIMS, and eDMS.</li> <li>
Strong communication, organization, and project management capabilities</li> </ul> <p> <strong>
Our offer:</strong> </p> <ul> <li>
A dynamic and rapidly growing work environment with internal development opportunities</li> <li>
Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction</li> <li>
Employee development through numerous internal and external training opportunities</li> <li>60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus</li> <li>
Access to the Swibeco benefits platform with discounts from external partners</li> <li>
Fresh, healthy and varied food in our staff restaurant</li> <li>
A wide range of free sports activities on the Bachem Campus</li> </ul> <p>
Would you like to drive innovation together with us?</p> <p>
We look forward to receiving your complete application documents via our application portal.</p> <p>
Learn more about the Bachem Group and get inspired by our exciting work environment at our location in Bubendorf!</p> </div> </div> </div>