Sr. Associate, Quality Assurance Compliance – US Distribution Quality,
Core
Provide tactical site support to ensure compliance with site, Alcon, and international regulations for US distribution quality.
Role type
Senior Associate, Quality Assurance Compliance (US Distribution)
Builds
Quality Management System (QMS) compliance and state licensing adherence
Domain
Healthcare / Ophthalmics / Regulatory Compliance
Required skills
Quality Management Systems (QMS), cGMP, GxP, ISO standards, state licensing management, gap assessment, corrective action implementation, regulatory research, documentation management
Preferred skills
Analytical skills, organizational skills, problem-solving, independent work, multi-priority management
Technologies
Quality Information Systems
Responsibilities
Support harmonization and continuous improvement of the Quality Management System (QMS); Manage quality processes including Complaints Management, Supplier Quality Management, and Training Programs; Conduct gap assessments and support implementation of corrective actions; Support preparation, submission, and renewal of state registrations, licenses, and permits; Monitor state laws and regulatory requirements; Communicate with state agencies regarding licensing and compliance inquiries.
Seniority
Senior, hands-on IC
