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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 & Regulatory leads, Group SHE Partner, and the Africa Legal, Compliance & Risk Chapter.
- External: Local Regulatory Authorities (e.g., EDA), Regional Distributors, 3PL Logistics Partners, Service Providers, and Industry Bodies (Mecomed, GHWP).
Who you are
- You hold a BSc degree in life sciences
- Extensive background in Quality Management Systems (QMS), regulatory submission frameworks (EDA/IVD/Medical Devices), and SHE guidelines in pharmaceutical, diagnostics, or life sciences sectors.
- Proven track record of successfully managing major regulatory inspections
- Strong analytical, risk management, and audit fieldwork experience, with proven skills in supplier assessment and deviation investigations.
- Executive communication, negotiation, and leadership skills to engage effectively with regulatory authorities.
- You demonstrate strong analytical skills to assess performance & impact, build and assess commercial models & identify strategic opportunities.
- You are customer centric and are able to analyze to understand the unmet medical needs
- You have advanced interpersonal, relationship building, communication and presentation skills
- You are resulted oriented and possess advanced negotiation skills, are able to apply logical reasoning and influence
- You are able to solve problems and take decision
- You fluently speak and write in English
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.
