Sr Associate, Quality Assurance

Position Overview

Join Alcon, a global leader in eye care innovation, where we are dedicated to enhancing sight and transforming lives through groundbreaking advancements in ophthalmology. As a Sr Associate, Quality Assurance, you will serve as a critical steward of our Quality Management System (QMS), ensuring unwavering compliance with global and local regulatory standards while safeguarding patient safety and product integrity. This role offers a unique opportunity to collaborate with cross-functional teams, drive operational excellence, and contribute to Alcon’s mission of delivering exceptional eye care solutions worldwide. Based in Riyadh, Saudi Arabia, you will play a pivotal role in maintaining the highest standards of quality, vigilance, and regulatory adherence in a dynamic and impactful environment.

Key Responsibilities

Quality Systems & Compliance

In this capacity, you will champion the effective implementation and continuous improvement of Alcon’s Quality Management System across all business operations. Your responsibilities will include ensuring strict adherence to regulatory frameworks such as GMP, GDP, ISO 13485, and EU-MDR (where applicable), as well as local regulatory requirements specific to the Kingdom of Saudi Arabia. You will review and approve critical quality documentation, including Quality Assurance Agreements, product returns, and Annual Product Quality Reviews, while overseeing product handling, storage, distribution, and release activities to guarantee compliance with all applicable standards.

Quality Operations & Continuous Improvement

As a key contributor to our quality operations, you will support critical QMS activities such as Corrective and Preventive Actions (CAPA), change control, risk management, management reviews, quality planning, and KPI monitoring. Your analytical expertise will be instrumental in conducting non-conformance investigations, performing root cause analyses, and implementing robust corrective and preventive actions. You will also play an active role in supplier audits, self-inspections, and supplier qualification initiatives to ensure the highest standards of quality throughout our supply chain. Additionally, you will identify quality risks, escalate critical issues promptly, and drive continuous improvement initiatives to enhance operational excellence and business effectiveness.

Vigilance Management & Regulatory Engagement

In this role, you will oversee post-market surveillance activities, ensuring full compliance with vigilance regulations and standards. You will collect, review, and evaluate post-market data from customers, distributors, healthcare providers, and other stakeholders to monitor product performance and safety. Serving as the primary liaison with the Saudi Food & Drug Authority (SFDA), you will coordinate responses to regulatory inquiries, requests for additional information, and inspection observations related to vigilance activities. Your responsibilities will include monitoring updates to SFDA vigilance regulations and guidance documents, supporting the implementation of regulatory changes within the QMS, and coordinating investigations of complaints and adverse events with internal stakeholders and manufacturers. You will also analyze complaint trends to identify potential safety signals requiring further evaluation.

Stakeholder Collaboration & Leadership

As a Sr Associate, Quality Assurance, you will partner closely with internal stakeholders across multiple functions to support quality-driven projects and initiatives. Your ability to collaborate effectively with cross-functional teams will be essential in maintaining high standards of quality and compliance while driving operational excellence. You will contribute to continuous improvement programs aimed at strengthening quality performance and enhancing business effectiveness, ensuring that Alcon remains at the forefront of innovation and regulatory compliance in the eye care industry.

Qualifications & Competencies

Education & Experience

• Bachelor’s degree in Pharmacy, Life Sciences, Engineering, Quality Management, or a related discipline.
• Minimum of 5 years of relevant experience in Quality Assurance, Regulatory Affairs, Medical Devices, Pharmaceuticals, Healthcare, or a regulated industry.
• In-depth knowledge of SFDA vigilance and post-market surveillance requirements.
• Strong understanding of Quality Management Systems, including ISO 13485 and applicable regulatory standards.
• Proven experience supporting audits, investigations, CAPA processes, and supplier quality activities.

Skills & Attributes

• Exceptional analytical, problem-solving, and critical thinking abilities.
• Strong communication and interpersonal skills, with the ability to collaborate effectively across functions.
• Proactive mindset with a keen attention to detail and a commitment to quality and compliance.
• Ability to manage multiple priorities in a fast-paced, dynamic environment.
• Proficiency in Microsoft Office Suite and familiarity with quality management software.

What You’ll Bring to Alcon

As a Sr Associate, Quality Assurance at Alcon, you will have the opportunity to make a meaningful impact on global eye health while advancing your career in a supportive and inclusive environment. You will bring a passion for quality, a commitment to excellence, and a proactive approach to identifying risks and driving continuous improvement. Your expertise will contribute to Alcon’s mission of enhancing sight and improving lives, while your leadership will inspire confidence in our products, processes, and people. Join us and be part of a team that is dedicated to making a difference in the world of eye care.