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QMS Document Manager

Roche14 days ago
Mississauga, Ontario, Canada
CA$136,936 - CA$179,729/annual
Senior Level
Full-Time

About the role

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. The Position At Roche, we are passionate about transforming patients’ lives. As a global leader in healthcare, we bring together cutting-edge science, innovative diagnostics, and targeted therapeutics to address some of the world’s most challenging medical needs. We believe that doing now what patients need next requires not only world-class innovation but also an unwavering commitment to quality, compliance, and operational excellence. Our Pharma Technical (PT) organization is at the heart of this mission, ensuring that our life-changing medicines are manufactured and delivered safely, reliably, and efficiently to patients worldwide. By joining Roche, you become part of a diverse, collaborative network dedicated to shaping the future of medicine. The Opportunity The QMS Governance team drives the delivery of PT Global QMS documents to enable effective implementation across our network. As the Global QMS Manager, you will provide global oversight for the development and maintenance of our global QMS documents, operating model, and digital tools. In this role, your key responsibilities will include: Managing the end-to-end QMS document process and coordinating cross-functional activities to ensure strict adherence to the overall QMS architecture and defined timelines. Providing global oversight for the sustainment, evolution, and continuous improvement of the QMS operating model to ensure maximum efficiency and effectiveness. Maintaining and improving our suite of QMS digital tools, including QMS Insights, QMS Navigator, QMS Stylus, QMS Search, and ProcessQ. Leading QMS Process Owner changes, managing comprehensive onboarding programs, driving communication channels, and establishing robust performance monitoring systems. Coordinating the prioritization of QMS workload based on risk assessments, customer requirements, and business impact. Building and maintaining strategic collaboration and alignment across various PT functions to ensure robust ownership, standardization, and a high-performing operating model. Communicating critical QMS changes, updates, and process improvements clearly and proactively to all mapped global and local stakeholders. Who you are You are a results-driven quality professional who thrives on collaboration, strategic thinking, and process optimization within a highly regulated global network. To be successful in this role, you bring the following qualifications: You possess an academic degree (or equivalent qualification) paired with at least 10 years of progressive experience within the pharmaceutical industry and GMP-regulated environments. You demonstrate extensive knowledge of pharmaceutical quality systems, industry standards, and global Health Authority regulations, with direct experience in document control systems. You bring a strong network mindset and exceptional communication and negotiation skills, enabling you to establish trustful, successful relationships with local and global colleagues. You are skilled at working effectively across multiple departments, sites, and cross-functional teams while managing multiple priorities accurately within tight timelines. You exhibit strategic and critical thinking skills, giving you the ability to make sound, risk-based decisions and determine pragmatic solutions to complex governance challenges. You are thorough, detail-oriented, and possess strong project management and collaboration skills to successfully drive initiatives from inception to execution. You are fluent in written and spoken English, possess the ability to travel internationally as needed (less than 5%), and ideally bring previous global or international work experience. Relocation not eligible for this position The expected salary range for this position based on the primary location of Mississauga is 136,936.00 and 179,728.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company. We use artificial intelligence to screen, assess or select applicants for this role. This posting is for an existing vacancy at Hoffmann-La Roche Ltd. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. 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.

About Roche

Biotechnology Research
10,000+
Founded in 1896

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).

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