Sr Associate, Quality Assurance

About Alcon

At Alcon, we are driven by a singular mission: to enhance sight and empower people to see brilliantly. With a global workforce of over 25,000 associates, we lead the charge in eye care innovation, fostering an environment where progress is not just encouraged but celebrated. Our inclusive culture values every contribution, offering unparalleled opportunities for professional growth and development. Together, we are committed to making a meaningful difference in the lives of patients and customers worldwide.

The Opportunity

As a Senior Associate in Quality Assurance, you will serve as a critical link in upholding and advancing Alcon’s Quality Management System (QMS), ensuring strict adherence to global and local regulatory standards. This role demands close collaboration with cross-functional teams to oversee quality operations, supplier management, audits, investigations, and continuous improvement initiatives. Your contributions will be pivotal in safeguarding product quality, patient safety, and operational excellence, reinforcing Alcon’s reputation as a leader in the healthcare industry.

Key Responsibilities

Quality Systems & Compliance

• Champion the implementation and awareness of the Quality Management System (QMS) across all business functions.
• Ensure compliance with global and local regulatory requirements, including GMP, GDP, ISO 13485, EU-MDR (where applicable), and Saudi Food & Drug Authority (SFDA) standards.
• Review and approve critical quality documentation, such as Quality Assurance Agreements, product returns, and Annual Product Quality Reviews.
• Support product handling, storage, distribution, and release activities in full compliance with regulatory and quality benchmarks.

Quality Operations

• Facilitate QMS activities, including Corrective and Preventive Actions (CAPA), change control, risk management, management reviews, quality planning, KPI monitoring, and SOP compliance.
• Conduct thorough non-conformance investigations and lead root cause analysis to implement effective corrective and preventive actions.
• Identify and escalate quality risks promptly, ensuring timely resolution of quality events.
• Participate in supplier audits, self-inspections, and supplier qualification processes to maintain high standards of quality and compliance.

Vigilance Management and Regulatory Interactions

• Support post-market surveillance activities, ensuring compliance with SFDA and other applicable regulations.
• Collect, review, and evaluate post-market data from customers, distributors, healthcare providers, and other stakeholders.
• Act as the primary point of contact with the SFDA for all vigilance-related communications, including responses to inquiries, requests for additional information, and inspection observations.
• Monitor updates to SFDA vigilance regulations, guidance documents, and reporting requirements, and support the implementation of these changes within the QMS.
• Coordinate investigations of complaints and adverse events with internal teams and external manufacturers.
• Analyze complaint trends to identify potential safety signals that require further evaluation.

Continuous Improvement & Stakeholder Collaboration

• Partner with internal stakeholders to support multiple projects while maintaining the highest standards of quality and compliance.
• Drive initiatives that enhance operational excellence and achieve quality KPIs.
• Contribute to continuous improvement programs aimed at strengthening quality performance and overall business effectiveness.

Qualifications

• Bachelor’s degree in Pharmacy, Life Sciences, Engineering, Quality Management, or a related field.
• Proven 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 other applicable regulatory standards.
• Hands-on experience supporting audits, investigations, CAPA processes, and supplier quality activities.
• Exceptional analytical, problem-solving, and communication skills.
• Ability to collaborate effectively across functions and manage multiple priorities in a dynamic environment.

What You’ll Bring

We are seeking a detail-oriented professional with an unwavering commitment to quality and compliance. Your proactive approach to identifying risks and driving solutions will be instrumental in maintaining Alcon’s high standards. If you are passionate about making a tangible impact in the healthcare industry and thrive in a collaborative, fast-paced environment, we invite you to join our team and contribute to our mission of enhancing sight worldwide.