• Performing the duties as Responsible Person for Medical Device and Medicinal products in Spain in accordance with local legislation.

• Ensuring that processes and procedures needed for an effective Quality System are established, implemented and maintained, including but not limited to, self-inspections, supplier qualifications, CAPA process, Quality Planning and SOP preparation.

• Gathering, maintaining and reporting key quality indicators for the country/cluster, and promote process improvements using lean methodology, self-inspections and CAPA/deviations system.

• Ensuring that products are received, stored, handled, distributed and transported according to regulatory requirements for the affiliate, by engaging with external Logistics Providers and ensuring that all Gx P suppliers are adequately qualified and monitored.

• Promoting a strong Quality Culture and awareness of regulatory and customer requirements throughout the affiliate.

• Driving awareness of the Quality System as a strategic platform for the business.

• Engaging affiliate personnel through development of adequate Gx P training and effective communication.

• Leading and providing guidance to non-conformance investigations ensuring formal structured approach to root cause analysis and problem solving, ensuring adequate corrective actions and prevention plans be implemented.

• Conducting audit preparation activities, facilitate, support and close out external audits by Health Authorities and Notified bodies, ensuring all corporate requirements are met and robust CAPAs implemented.

• Ensuring continuous Quality System Compliance by adherence to established and evolving Alcon and regulatory requirements.

• Bachelor’s degree in pharmacy, with the ability to practice as a pharmacist in Spain.
• Preferred master’s degree in Pharmaceutical Industry, Quality Management, or an MBA.
• Fluent in Spanish, with an upper-intermediate level of English. Knowledge of Catalan is a plus.
• Minimum of 2-5 years in Quality Assurance or a related role within the pharmaceutical or medical device industry, including distribution, commercial organizations, or manufacturing.
• Regulatory Knowledge: Proficient in relevant standards such as EU drug GDP, ISO 13485:2016, and EU MDR.
• Supplier Management: Experience in managing third-party suppliers.
• Direct experience with Health Authorities and notified bodies is highly valued.
• Preferred Commercial QA Experience: Quality Assurance experience in a commercial business setting.
• Experience in supply chain management or finished product distribution is highly appreciated.
• Certified Quality Auditor is nice to have

• Competitive salary
• Comprehensive benefits package
• Training and continuous development; Be part of a high performing leader in ophthalmology company with a lot of opportunities to further develop your professional career.
• International exposure
• Open, friendly and collaborative culture; Work in a challenging environment with an outstanding team that will support him to achieve goals and performance.