(Associate) Manager, QS & Compliance, Biologics

About this role

<p>At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come

Join Roche, where every voice matters.</p><h3></h3><p style="text-align:inherit"></p><h3>The Position</h3><p><b>Quality and Technical Guidance</b></p><ul><li><p><span>Support mobilisation of new sites from a quality, compliance perspective.</span></p></li><li><p><span>Develop and roll out resources in order to ensure full compliance with Roche’s quality management system (QMS)</span></p></li><li><p><span>Oversee Technical Change Control process. Act as the Chair of Local Change Review Board to</span> <span>ensure the effectiveness of the process.</span></p></li><li><p><span>Oversee Risk Management and provide relevant tools and expertise. </span></p></li><li><p><span>Effective governance and internal communication / escalation within Roche PT organization.</span></p></li><li><p><span>Present quality compliance status information, data analysis, metrics and general overviews to client management or internal customers</span></p></li><li><p><span>Provide strategic direction and manage execution of regulatory inspections, internal and external</span> <span>audits and paper-based inspections.</span></p></li><li><p><span>Provide strategic direction and oversight for the establishment and execution of the site self-inspection program

</span></p></li><li><p><span>Execute various processes (e.g. QMS / documentation control, change control) in compliance to relevant standards.</span></p></li><li><p><span>Produce monthly reports to regional management teams highlighting successes and hot spots</span></p></li><li><p><span>Develop and deliver training programs

Apply for this role on Roche’s official careers site.