Business Capability Lead - Release

Roche; Mississauga; On-site; CAD 137,000 - 180,000; Full time

Job summary

Roche in Mississauga is seeking a Senior Release Architect to act as a strategic partner for a global product release ecosystem. You will govern release standards, drive data-driven improvements, and collaborate with QA, manufacturing, and IT to ensure end-to-end data integrity.

You bring 10+ years in a GxP environment, strong regulatory knowledge, and a proven ability to lead cross-functional initiatives without direct authority.

Qualifications

• 10 years in a GxP-regulated environment (QA, Manufacturing, or Pharma Operations).
• Hands-on experience with quality release processes and ERP systems.
• Strong knowledge of international regulatory frameworks (FDA, EMA, ICH).
• Ability to lead cross-functional initiatives without direct authority.

Responsibilities

• Architect fit-for-future release standards and govern the release roadmap, including platform stabilization and system modernization.
• Lead global standards integration for External Release and ensure robust global controls.
• Optimize interfaces between release systems, QA organizations, and manufacturing partners.
• Collaborate with global stakeholders to drive operational excellence and agile ways of working.
• Drive quality compliance and continuous improvement, owning deviations, changes, and CAPAs.
• Support supplier qualification interfaces within the release process and governance of SOPs.

Skills

GxP experience

Quality release processes

Regulatory knowledge

Cross-functional leadership

Education

Bachelor's or Master's degree in a scientific, technical, or business field, or equivalent practical experience

Tools

SAP/S4 systems

Job description

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 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 role is not eligibele for relocation

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.