Business Capability Specialist - Quality

Roche • Mississauga, ON

2d • CA$105,560 - CA$138,548 • Onsite

About 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. 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).

Requirements

• Hold a Bachelor's degree in Life Sciences, Engineering, Computer Science, or a related field, or an equivalent technical/vocational qualification.
• Bring 5+ years of hands-on experience working within a heavily regulated GxP environment (Pharma, Biotech, or MedTech).
• Possess deep, expert-level navigation experience within SAP (preferably S/4HANA) and Quality Systems (such as Veeva Vault Quality / BRH).
• Have a strong, practical understanding of regulatory requirements (including GMP Annex 11), Quality Systems, Computer Systems Validation (CSV), and Root Cause Analysis (RCA) methodologies.
• Be highly proficient in formulating, structuring, and writing rigorous technical investigations and robust CAPA plans with meticulous attention to detail.
• Have excellent interpersonal skills, utilizing professional persistence to effectively chase stakeholders for approvals and evidence without damaging cross-functional relationships.
• Be 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.

Responsibilities

• Serve 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).
• Manage 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.
• Coordinate Planned Events: Lead the documentation and coordination of planned system enhancements, maintenance, and upgrades, ensuring all quality impact assessments are robust and pre-approved.
• Execute 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.
• Ensure 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.
• Drive 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.
• Lead 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level