As Manager, Quality Assurance, you will build and lead the Quality function for Saudi Arabia, establishing systems that align with global standards and local regulations. This role is central to ensuring product integrity across storage, distribution, and compliance frameworks.
What You'll Do
You will design and implement the Quality Management System from inception, ensuring adherence to ISO 13485, GDP, EU-MDR (where applicable), and Saudi-specific requirements. Serve as the primary contact during regulatory inspections and coordinate responses to findings with timely corrective actions.
Oversee batch record reviews, product release procedures, and supplier quality performance. Lead investigations into non-conformances and ensure effective CAPA processes are in place. Act as the Quality Management Representative and, when necessary, the Responsible Person for wholesale distribution activities.
Direct vigilance and technovigilance reporting to local authorities, maintaining compliance with mandatory timelines. Collaborate with regional and global teams to integrate quality practices across functions and support market expansion.
Requirements
- Bachelor’s degree in a scientific or engineering field
- Minimum of 5 years in quality roles within medical devices or pharmaceuticals
- Proven understanding of ISO 13485, 21 CFR Part 820, and GDP
- Experience managing regulatory inspections and audit follow-up
- Strong grasp of vigilance and technovigilance reporting obligations
- Fluency in English with clear, effective communication skills
- Ability to work independently in a fast-changing environment
Preferred Qualifications
- Experience with SAP or similar enterprise systems
- Prior leadership or team management roles
- Knowledge of Saudi regulatory expectations
Benefits
- Shape a new Quality function and organizational structure from the ground up
- Grow your career in a high-potential market with access to regional leadership
- Work in a collaborative, international setting that values initiative
- Relocation support may be available
