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Roche

Business Capability Lead – Release

Roche

. Act as a strategic partner to the Global Release Business Process Owner .

Posted 10/19/2026full-timeMississauga • CanadaSenior💰 CA$136,936 - CA$179,729 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in architecting and governing global product release processes within GxP-regulated environments, ensuring compliance with international regulatory frameworks while driving operational excellence and continuous improvement.

Highest-signal resume keywords
GxP-Regulated Environment ExperienceInternational Regulatory Frameworks KnowledgeQuality Release Processes ManagementCross-Functional Initiative LeadershipData-Driven Problem-Solving

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Enterprise SAP/S4 SystemsBusiness Process ManagementQuality AssuranceProcess Health MonitoringChange Control ManagementCAPA ManagementProcess Flow DesignStandard Operating Procedures DevelopmentData Integrity OptimizationQuality Records Management
Soft Skills
Exceptional Problem-Solving AbilitiesClear Communication of Complex RequirementsCollaboration with Global StakeholdersAgile Working MethodsChange Guidance
Industry Keywords
FDAEMAICHPharmaceutical OperationsManufacturingQuality ComplianceOperational ExcellenceProcess HarmonizationSupplier QualificationGlobal Standards Integration

Tech Stack

Tools & technologies
ERP

About the role

Key responsibilities & impact
  • Act as a strategic partner to the Global Release Business Process Owner
  • Architect, govern, and safeguard the global product release ecosystem
  • Drive organizational efficiency, compliance, and process harmonization across the global network
  • Design future-ready release standards and govern the release roadmap, including platform stabilization, continuous improvement, and system modernization such as 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 with global stakeholders to gather insights, drive operational excellence, and embed agile, collaborative ways of working
  • Drive quality compliance and continuous improvement as process owner for quality records including deviations, change controls, and CAPAs
  • Monitor process health using data-driven metrics
  • Support supplier qualification interfaces within the release process
  • Maintain global process governance, including updating process flows, design documentation, and network standard operating procedures

Requirements

What you’ll need
  • Bachelor’s or Master’s degree in a scientific, technical, or business field, or equivalent practical experience
  • 10 years Proven experience within a GxP-regulated environment (e.g., Quality Assurance, Manufacturing, or Pharmaceutical Operations)
  • Strong working knowledge of international regulatory frameworks (e.g., FDA, EMA, ICH)
  • Hands-on experience with quality release processes, business process management, and enterprise quality/ERP systems
  • Strong capability to lead cross-functional initiatives, guide change, and align multi-disciplinary teams without direct hierarchical authority
  • Exceptional problem-solving abilities with a data-driven mindset
  • Ability to articulate complex process requirements clearly to diverse stakeholders
  • This role is not eligible for relocation