Jobs at Roche

Lead country study start-up strategy and operations to enable timely site activation and regulatory compliance. Drive process standardization, automation, budgeting and contract negotiation, collaborate with regional/global teams, and engage external stakeholders to improve trial start-up timelines.

Support continuous improvement and operational excellence by identifying process gaps, partnering with Legal & Compliance, negotiating contracts, coordinating vendor management, and developing fit-for-purpose solutions. Communicate recommendations, share best practices across the SEA network, and adapt to a fast-paced, matrixed environment while prioritizing tasks and driving value for the business.

Lead QA and validation for AI/ML systems in a GxP/GMP environment. Collaborate with data science, IT and business to design, validate, implement, and operate AI solutions under CSV/CSA. Author validation documentation, mitigate model and data risks, align stakeholders on compliant strategies, and drive continuous improvement and capability building in digital validation and model governance.

Lead global microbiological QC modernization by evaluating and implementing rapid and molecular methods, authoring validation and regulatory dossiers, and directing cross-site harmonization projects. Provide expert scientific consultation, troubleshoot complex investigations and OOS events, and represent Roche in international regulatory working groups to set global QC standards.

Lead enterprise resourcing, workforce planning, budgeting, and metrics for PDD. Oversee forecasting, governance, data quality, tooling (Anaplan/Tableau/PowerBI), and a global team to enable data-driven decision making, resource optimization, and executive reporting across portfolio and finance stakeholders.

Develop and optimize software components and pipelines for Roche's SBX sequencing platform. Implement and maintain production-ready code (Python, C/C++), CI/CD, containerized ML deployments, and efficient genomic data processing using HPC or cloud resources (SLURM, AWS/GCP). Collaborate on algorithm implementation, performance profiling, and workflow engineering (Nextflow/Airflow).

Design and deploy autonomous AI agents and multi-agent systems to automate clinical trial data cleaning, validation, and analysis. Build agentic workflows, ensure GxP-compliant traceability, deploy on AWS with containerized CI/CD pipelines, integrate vector databases and RAG, and create HITL processes with Data Integrity and Quality teams to meet regulatory requirements.

Lead global clinical study planning and supply strategy for Roche/Genentech's clinical portfolio. Drive capacity and resource planning, process standardization, and capability development. Manage cross-functional stakeholder relationships, mitigate stockout risks, and champion continuous improvement. Serve as Mississauga site head, mentor teams, and represent PTDS in network-level strategic initiatives to ensure reliable clinical trial supply.

Lead safety strategy and pharmacovigilance for complex molecules across the product lifecycle. Provide expert review for safety decisions, regulatory submissions (IND/NDA/MAA), risk management plans, and mentor colleagues. Influence cross-functional stakeholders, apply statistical analyses to safety data, and represent safety expertise to regulators and leadership to ensure patient safety and data reliability.

Lead field-based implementation of diagnostic solutions across hospitals. Own a portfolio of long-term projects, ensure timely installations, align stakeholders, report on milestones, drive PMO continuous improvement, and provide tools, plans and capacity data to support successful project delivery.