Senior Quality Assurance Operations Manager (QP)

Rottapharm Limited<p></p><p></p><p>At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.<br/><br/>Viatris empowers people worldwide to live healthier at every stage of life.<br/><br/>We do so via:  <br/><br/>Access – Providing high quality trusted medicines regardless of geography or circumstance;<br/>Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and  <br/>Partnership – Leveraging our collective expertise to connect people to products and services.  <br/> </p><p>Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.</p><p></p><p>For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.</p><p></p><p>The Role &amp; What You Will Be Doing</p><p>Every day, we rise to the challenge to make a difference and here’s how the Senior Quality Assurance Operations Manager role will make an impact:</p><ul><li><p>Ensure that the manufacture and release of site products are in alignment with QP EU directives, relevant health authority submissions, cGMPs as well as company policies and procedures.</p></li><li><p>Provide strategic and technical input into site initiatives related to product transfers and systems implementations associated with manufacturing, packaging and/or cleaning processes.</p></li><li><p>Principal contact for systems implementations which are directly related to materials, cleaning and product disposition (e.g. SAP &amp; MEB).</p></li><li><p>Provide appropriate evaluations and coordination for changes related to products, manufacturing/packaging/cleaning equipment or processes as well as incoming materials.</p></li><li><p>Provide effective Quality Leadership during internal and regulatory inspections.</p></li><li><p>Manage and conduct the site approvals for product and material investigations as well as specific procedures related to direct operational and cleaning activities, process validations (manufacturing, packaging and cleaning), ongoing process verifications, master batch documentation (in manual and electronic systems), product specifications, testing method validations and these systems related CAPAs.</p></li><li><p>Determine group structure, ensure the development of talent for effective succession and carry out performance assessments of department sub-ordinates.</p></li><li><p>Assure an efficient performance of the processes associated to assigned approvals, product disposition, etc. through the continuous review of resources and systems throughput and the implementation of new tools, technology and business processes.</p></li><li><p>Recommend actions or policies that result in compliance enhancements and inspection readiness.</p></li><li><p>Maintain a leadership role in establishing and promoting quality improvement activities as a foundation for productivity improvement and business success for the site, including commitment to Operational Excellence.</p></li><li><p>Coordinate the forecasting process for required business statistics/information and reporting as well as the operational/expense budget and capital budget.</p></li><li><p>Manage and maintain robust relationships with the Viatris internal leadership team, industry colleagues and with the HPRA &amp; FDA organisations.</p></li></ul><p></p><p>About Your Skills &amp; Experience</p><p>For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:</p><ul><li><p>Bachelor’s degree in a relevant field, such as Pharmacy, Chemistry, Biology or a related discipline.</p></li><li><p>An advanced degree (Master’s or Ph.D.) is preferably, but not mandatory.</p></li><li><p>QP entitled with proven experience</p></li><li><p>5-7 years of extensive experience in quality assurance, regulatory compliance or a related area within the pharmaceutical industry, with a focus on compliance with GMP, GLP and regulatory requirements.</p></li><li><p>Experience in managing compliance programmes, ensuring adherence to regulatory standards, and implementing quality systems.</p></li><li><p>In-depth knowledge of relevant regulations and guidelines, such as EMA, ICH and other global regulatory requirements.</p></li><li><p>Leadership and people’s management skills.</p></li></ul><p></p><p>At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past ex