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Business Capability Lead - Release
Job in
Mississauga, Ontario, Canada
Listed on 2026-10-21
Listing for:
Roche Holding AG
Full Time
position Listed on 2026-10-21
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Join Roche, where every voice matters.
The Position
At Roche, we are passionate about transforming patients’ lives. As a global healthcare leader operating in over 100 countries, we combine the strengths of our Pharmaceuticals and Diagnostics divisions to drive the future of personalized healthcare. We thrive on innovation, scientific excellence, and a shared commitment to delivering sustainable, high-quality medical solutions.
As part of our ambitious 10-year Pharma vision, we are dedicated to delivering more benefits to patients by integrating innovative technology and systems into our lifecycle management processes. By joining Roche, you will be part of a dynamic, diverse, and inspiring environment where your work has a direct, meaningful impact on patients worldwide.
The Opportunity
In this role, you will act as a strategic partner to the Global Release Business Process Owner, serving as an architect, governor, and guardian of our global product release ecosystem. You will drive organizational efficiency, compliance, and process harmonization across our global network.
Architect fit-for-future release standards and govern the release roadmap, including platform stabilization, continuous improvement, and system modernization (e.g., enterprise SAP/S4 systems).
Lead global standards integration for External Release , ensuring externally manufactured products are governed by streamlined, automated, and robust global controls.
Optimize process interfaces between global release systems, external quality organizations, and manufacturing partners to enhance end-to-end data integrity.
Collaborate cross-functionally with global stakeholders to gather insights, drive operational excellence, and embed agile, collaborative ways of working.
Drive quality compliance and continuous improvement , serving as a process owner for quality records (deviations, change controls, CAPAs) and monitoring process health using data-driven metrics.
Support supplier qualification interfaces within the release process to strengthen data integration and overall process compliance.
Maintain global process governance , including updating process flows, design documentation, and aligning network standard operating procedures (SOPs).
Who You Are
You are a strategic, quality-minded professional who thrives on bridging complex technical processes with business operations, fostering collaboration across multi-disciplinary global networks.
Educational Background: Bachelor’s or Master’s degree in a scientific, technical, or business field, or equivalent practical experience.
Industry Expertise: 10 years Proven experience within a GxP-regulated environment (e.g., Quality Assurance, Manufacturing, or Pharmaceutical Operations) with strong working knowledge of international regulatory frameworks (e.g., FDA, EMA, ICH).
Process Architecture & Systems: Hands-on experience with quality release processes, business process management, and enterprise quality/ERP systems.
Leadership & Influence: Strong capability to lead cross-functional initiatives, guide change, and align multi-disciplinary teams without direct hierarchical authority.
Analytical & Communication
Skills:
Exceptional problem-solving abilities with a data-driven mindset and the ability to articulate complex process requirements clearly to diverse stakeholders.
This…
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