Business Capability Specialist - Quality

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

***24 month contract 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

We are seeking a proactive and pragmatic Business Capability Specialist to join our Pharma Technical Quality (PTQ) ASPIRE Sustainment team. In this role, you will serve as the primary tactical driver owning the lifecycle of Deviations, CAPAs, and Planned Events, bridging the gap between intricate quality challenges and compliant technical solutions within our ERP and Quality Systems (SAP S/4HANA, BRH).

Your core responsibilities will include:

• Serving as the Technical Subject Matter Expert: Act as the hands-on expert for SAP S/4HANA and BRH systems, serving as the primary author for system-related deviations, leading technical investigations, and performing Root Cause Analysis (RCA).

• Managing System Lifecycle and CAPAs: Own the end-to-end lifecycle of Corrective and Preventive Actions (CAPAs), tracking milestone completion and verifying the effectiveness of implemented solutions to prevent recurrence.

• Coordinating Planned Events: Lead the documentation and coordination of planned system enhancements, maintenance, and upgrades, ensuring all quality impact assessments are robust and pre-approved.

• Executing Tactical Change Management: Support the Strategy Lead by executing the tactical steps of IT Change Requests while ensuring all Computer Systems Validation (CSV) documentation is audit-ready and compliant with GMP Annex 11.

• Ensuring System Health and Sustained Operations: Monitor daily system health in SAP and BRH to proactively identify process pain points and resolve technical bottleneck red flags before they escalate into critical incidents.

• Driving Data Integrity and Governance: Harvest high-quality data from QMS and ERP systems to populate strategic KPIs and dashboards, acting as a steward for record data integrity.

• Leading Audit Readiness and Cross-Functional Collaboration: Maintain a constant state of audit readiness, serving as the primary SME for record walkthroughs during inspections, while collaborating with IT and Business Process Owners to unblock stalled records.

Who you are

You are a collaborative, open-minded professional who values continuous learning, thrives in dynamic environments, and balances a strict compliance mindset with a focus on impactful execution.To be successful in this role, you bring the following qualifications and skills:

• You hold a Bachelor's degree in Life Sciences, Engineering, Computer Science, or a related field, or an equivalent technical/vocational qualification.

• You bring 5+ years of hands-on experience working within a heavily regulated GxP environment (Pharma, Biotech, or MedTech).

• You possess deep, expert-level navigation experience within SAP (preferably S/4HANA) and Quality Systems (such as Veeva Vault Quality / BRH).

• You have a strong, practical understanding of regulatory requirements (including GMP Annex 11), Quality Systems, Computer Systems Validation (CSV), and Root Cause Analysis (RCA) methodologies.

• You are highly proficient in formulating, structuring, and writing rigorous technical investigations and robust CAPA plans with meticulous attention to detail.

• You have excellent interpersonal skills, utilizing your professional persistence to effectively chase stakeholders for approvals and evidence without damaging cross-functional relationships.

• You are skilled at managing tasks via modern agile frameworks (e.g., Jira) and possess the business acumen required to deliver compliant solutions in a complex organizational landscape.

**Relocation not eligible for this position**

The expected salary range for this position based on the primary location of Mississauga is 105,560.00 and 138,547.50 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.