Technical Manager, Quality Process Management - Apqr - 12 Month Contract Position

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.A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.The Technical Manager, Quality Process Management - APQR, supports and executes the APQR process per Annual Product Quality Review (APQR) Requirements and Annual Product Quality Review (APQR) Process for Roche commercial products to identify trends and issues that affect the overall state of control of products and their manufacturing process throughout their life cycle, and, if necessary, to describe appropriate actions for product quality issues.12 Month Contract Position
The Opportunity
You will conducts annual single-site and E2E reviews to deliver site and E2E APQR reports per requirements in REQ-0300212 and sop028938.You will support the compilation of APQR reports via the acquisition, visualization, and analysis of data from sites across the Roche network.You will work with APQR stakeholders to identify, elevate, and resolve product quality issues and Proposing APQR actions items, as needed.You will support the development, maintenance, and execution of Global APQR systems, projects, and administrative activities.You will support APQR and Quality oversight activities while ensuring cross-functional team deliverables are completed in a compliant, accurate, high quality and timely manner.Who you are
You will have a B.A., B.S. or Higher degree (preferably in Life Science)with 3- 5 years of applicable cGMP pharmaceutical or biopharmaceutical or related industry, or an equivalent combination of education and experience.You will bring the ability to lead cross-functional teams, resolve complex technical, quality, and business process-related issues;
extract optimized business results through skillful collaboration and application of principles for influencing without formal authority.Your technical expertise in small and large molecule drug substance and drug product manufacturing processes and associated control and documentation systems.Including knowledge of medical devices and device combination products is desirable.Experience with enterprise database management, cloud-based collaboration platforms, and electronic Quality Management Systems (eQMS like Veeva, TrackWise).Demonstrated proficiency in digital analytics and visualization tools (e.G., Tableau, Power BI, Spotfire, or SQL) to automate reporting and interpret complex manufacturing/quality datasets.Relocation benefits not eligible for this position.The expected salary range for this position based on the primary location of Mississauga is 89,256.00 and 117,148.50 of hiring range.This posting is for an existing vacancy at Hoffmann-La Roche Ltd.We use artificial intelligence to screen, assess or select applicants for this role.Roche is an Equal Opportunity Employer.We believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients' lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.
#J-18808-Ljbffr