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Roche is a global pioneer in pharmaceuticals and diagnostics, focused on advancing science to improve people’s lives. As the world’s largest biotech company and a leader in in-vitro diagnostics, we are committed to delivering personalized healthcare and driving innovation across the medical spectrum. Our success is built on a diverse and inclusive workforce dedicated to tackling the most complex healthcare challenges. At Roche, you will join a team of passionate professionals working in an environment where every contribution has the potential to impact patients worldwide.
The Global Lead, Engineering Content & Document Management is responsible for the strategic design, implementation, and governance of the information management framework within the Global Engineering function. This role ensures that all technical documentation and engineering content—integral to the design, construction, and qualification of pharmaceutical manufacturing assets—are managed according to international best practices and stringent regulatory requirements. You will lead the transition from traditional document control to a Digital Project Delivery model, ensuring high data integrity and seamless information exchange across a global portfolio of capital projects.
The Opportunity:
Define and maintain the Global Engineering Document Management strategy, ensuring full alignment with ISO, GxP regulatory requirements, and internal Roche standards.
Establish comprehensive document control procedures, including standardized metadata, taxonomies, and lifecycle workflows from Work-in-Progress to Archiving.
Oversee the "Handover to Operations" process to guarantee that all technical documentation is audit-ready and seamlessly integrated into Site Facilities Management systems.
Serve as the functional lead for the Common Data Environment (CDE), facilitating interoperability between document management systems and BIM workflows.
Lead periodic audits and provide rigorous oversight for external EPC partners to ensure strict adherence to corporate information and quality standards.
Act as the primary liaison between Global Engineering, IT, Quality Assurance, and Legal departments to harmonize digital information management.
Drive the evolution of digital project delivery by implementing digital twins and automated metadata extraction to reduce information loss during transitions.
Who you are:
You possess a Master’s or Bachelor’s degree in Engineering, Information Science, or a related technical discipline.
You bring a minimum of 8–10 years of experience in technical document or information management, ideally within the Pharmaceutical or Biotech industries.
You are a subject matter expert in BIM Level 2/3 requirements and the ISO 19650 suite of standards for information management.
You demonstrate advanced proficiency with Enterprise Content Management platforms such as OpenText, Veeva Vault, or Autodesk Construction Cloud.
You have a comprehensive understanding of GxP, the validation lifecycle (V-Model), and ALCOA+ data integrity principles.
You are skilled at leading cross-functional teams and managing external vendors within a complex, global matrixed environment.
You possess the strategic vision necessary to anticipate the evolution of digital engineering and translate complex requirements into structured information architectures.
***Relocation benefits not available for this position***
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.
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.