QMS Document Manager
About 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.
Requirements
- An academic degree (or equivalent qualification) paired with at least 10 years of progressive experience within the pharmaceutical industry and GMP-regulated environments.
- Extensive knowledge of pharmaceutical quality systems, industry standards, and global Health Authority regulations, with direct experience in document control systems.
- A strong network mindset and exceptional communication and negotiation skills, enabling you to establish trustful, successful relationships with local and global colleagues.
- Skilled at working effectively across multiple departments, sites, and cross-functional teams while managing multiple priorities accurately within tight timelines.
- Strategic and critical thinking skills, giving you the ability to make sound, risk-based decisions and determine pragmatic solutions to complex governance challenges.
- Thorough, detail-oriented, and possess strong project management and collaboration skills to successfully drive initiatives from inception to execution.
- Fluent in written and spoken English.
- Ability to travel internationally as needed (less than 5%).
Nice To Haves
- Previous global or international work experience.
Responsibilities
- 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.
Benefits
- We use artificial intelligence to screen, assess or select applicants for this role.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
