Sr. Director, Quality Leadership (QLT)

About the role

Alcon is seeking a senior leader to head the Quality Leadership Team (QLT) within its Quality & Regulatory Affairs function. The role oversees the total quality system for one or more manufacturing plants, ensuring compliance with global, local and internal regulations while driving continuous improvement.

Key responsibilities

• Manage and direct Quality Assurance departments, including Quality Systems, Documentation Control, Quality Control, Quality Engineering, Regulatory Affairs, Complaint Handling and Laboratory Services.
• Ensure compliance with FDA Quality System Regulations (QSR), ISO 13485, EU MDR, MDSAP and other applicable standards.
• Lead implementation of Quality Management System tools, process improvements and post‑market surveillance actions.
• Act as Facility Management Representative and local Management Representative for ISO compliance.
• Oversee budget, staffing and succession planning for the Quality Assurance function.

Required profile

• Bachelor’s degree (or equivalent scientific qualification for designated roles).
• 12 + years of relevant experience, including 8 + years of demonstrated leadership in quality or regulatory affairs for medical devices.
• Fluent English communication skills.
• Willingness to travel 5‑10 %.

Required skills

• In‑depth knowledge of FDA QSR, ISO 13485, ISO 14000, EU MDR 2017/745, MDD, MDCG guidance and MDSAP requirements.
• Experience with Quality Management Systems, audit preparation and regulatory compliance.
• Ability to manage cross‑functional quality teams and drive continuous improvement.