<p>Senior Specialist / QA Manager (CMO Operations – Small Molecules)</p><p><br /><br />Location: Morges, Switzerland (Up to 2 days of remote work per week) <br />Contract Type: Temporary – Starting ASAP (possibility of extension)<br />Language: Fluent English (C1) required<br /> </p><p>Due to a significant increase in our client activities, we are looking for a Senior Specialist or QA Manager to reinforce a dynamic team of 4 people.<br /><br />This role is 100% focused on managing the Contract Manufacturing Organizations (CMOs) for small molecules.<br />You will oversee external operations, covering the entire supply chain from Active Pharmaceutical Ingredient (API) manufacturing up to primary packaging.</p><h3> </h3><p>Responsabilities<br />You will act as a true hands-on reinforcement to support the team in daily Quality operations. Expect a fast-paced environment with a high volume of work:</p><ul><li><p>Routine Batch Release: Perform rigorous documentary reviews and centralize information for the commercial products.</p></li><li><p>Supplier Relations: Manage day-to-day interactions and monitor the performance of the CMO partners.</p></li><li><p>Event Management: Take charge of the review and processing of product complaints.</p></li><li><p>Technical Support: Assist the team with the compilation and review of Annual Product Quality Reviews (APQR).</p></li><li><p>Continuous Improvement: Participate in document reviews as part of the ongoing implementation of our new LIMS system.</p></li></ul><h3> </h3><p>Profile<br />We need a hands-on professional who thrives in an operational setting and can get up to speed quickly.</p><ul><li><p>Education: Academic degree in a scientific field (Pharmacy, Biotechnology, Chemistry, etc.).</p></li><li><p>Experience: Proven track record in operational Quality Assurance. Specific experience with "commercial" products is not strictly mandatory if you have strong clinical QA experience and are a fast learner.</p></li><li><p>Hard Skills: You ideally possess a solid understanding of API (Active Pharmaceutical Ingredient) manufacturing oversight.</p></li><li><p>Soft Skills: You are flexible, proactive, and capable of adapting quickly in a highly active environment.</p></li></ul>