# Head of Quality, Regulatory & SHE at Roche

Roche is hiring a Head of Quality, Regulatory & SHE. Level rates it Little AI ●○○○; you can [apply on Level](https://jobsbylevel.com/go/df0e31e1-505f-458d-b282-ed6460ff8404?utm_medium=ai-agent).

AI Level 1, AI centrality 38 out of 100. Giza.

## Details

- Company: [Roche](https://jobsbylevel.com/companies/roche)
- AI level: AI Level 1 (score 38 out of 100)
- Location: Giza
- Posted: October 12, 2026
- Apply: https://jobsbylevel.com/go/df0e31e1-505f-458d-b282-ed6460ff8404?utm_medium=ai-agent

## 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 The Head of Quality, Regulatory & SHE executes and governs market-level compliance, quality assurance, safety protocols, and regulatory strategy across Egypt and the North Africa Network in alignment with corporate standards and local health authority requirements. The role combines hands-on operational leadership over Quality Operations and Safety, Health & Environment (SHE) with executive management of the Regulatory Affairs team , while serving as a full-seated member of the local Leadership Team to align risk management with strategic commercial objectives. Your Impact: 1. Leadership Team Governance & Strategic Alignment Executive Representation: Serves as a core member of the Leadership Team, representing Quality, Regulatory, and SHE interests across all commercial and operational initiatives. Management Reviews & Risk Governance: Conducts periodic management reviews on Quality Management System (QMS) performance, maintaining territory risk reports and monitoring mitigation progress for senior management. Industry & Stakeholder Engagement: Collaborates with local health authorities, trade associations (e.g., Mecomed, GHWP), and regional leadership to shape regulatory strategies and industry standards. 2. Quality Operations (Hands-On Execution) QMS & Corporate Quality: Ensures full compliance with Regional QMS, Divisional Directives, and complaint management KPIs. Supply Chain Quality: Oversees local supply chain quality and warehousing protocols, managing product returns, lot restrictions, quarantines, cargo insurance claims, and temperature deviation investigations. Post-Market Surveillance & Safety Actions: Acts as the primary local contact for Safety Board notifications, reportable incidents (PRI), potential safety issues (PSI), and Corrective Field Actions (CFA) / Product Removals in coordination with RCSC Dubai and local health authorities. 3. SHE & Site Security Operations (Hands-On Execution) Designated SHE & Security Lead: Functions as the local SHE Officer and Site Security Officer. Operational Safety Execution: Implements local environmental, health, and site security protocols, conducts compliance spot checks, and leads regular safety and compliance training sessions. 4. Regulatory Team Leadership & Oversight Team Direction & Registration Strategy: Directs the Regulatory team, allocating resources to build and execute the annual registration plan for medical devices and IVDs in Egypt and NAN countries. Authority Submissions & Approvals: Owns product registration submissions, approvals, pre-importation clearances, promotional material approvals, and authority interactions with bodies like the Egyptian Drug Authority (EDA). Regulatory Governance & Intelligence: Establishes tracking systems to provide complete visibility to Sales, Marketing, and Supply Chain teams, while analyzing regulatory changes to advise global and regional regulatory functions. Decision-Making Power & Strategic Authority: Exercises decision-making authority to execute local compliance activities, product quarantines, or field actions in agreement with the General Manager and Regional Quality Manager. Escalates critical compliance, quality, or regulatory risks directly to top management and regional compliance leadership. Recommends and manages resource allocations for quality, regulatory, and SHE initiatives across the network. Key Internal & External Work Relationships: Internal: General Manager, Leadership Team members, Directors/Function Heads, Regional Quality &

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/head-of-quality-regulatory-she-at-roche-edbaa7

Source: https://jobsbylevel.com/jobs/head-of-quality-regulatory-she-at-roche-edbaa7

## Cite this page

Level. https://jobsbylevel.com/jobs/head-of-quality-regulatory-she-at-roche-edbaa7.

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