Sr. Associate, Quality Assurance Compliance – US Distribution Quality,

Alcon•Fort Worth, TX

7h•Onsite

About The Position

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Sr. Associate, Quality Assurance Compliance – US Distribution Quality, is primarily responsible for providing tactical site support to ensure compliance with site, Alcon, and international regulations. You will independently coordinate site gap assessments and apply advanced knowledge and skills to achieve objectives through self-directed work at our Facility in Fort Worth, TX.

Requirements

Appropriate education, training, and experience to successfully perform the responsibilities of the role.
Knowledge of Quality Management Systems, cGMP, GxP, ISO standards, and regulatory compliance requirements.
Strong analytical, organizational, and problem-solving skills.
Ability to work independently, manage multiple priorities, and adapt in a dynamic regulatory environment.
Strong attention to detail and commitment to quality and compliance.
Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
The ability to fluently read, write, understand and communicate in English
2 Years of relevant experience

Responsibilities

Support the harmonization, standardization, and continuous improvement of the Quality Management System (QMS).
Manage quality processes including Complaints Management, Supplier Quality Management, Quality Information Systems, and Training Programs.
Conduct gap assessments and support implementation of corrective actions to maintain compliance with Alcon, regulatory, and international quality requirements.
Support Quality Strategy execution and governance activities, identifying opportunities to improve quality system effectiveness and operational efficiency.
Independently research, analyze, and resolve quality and compliance-related issues.
Maintain compliance with cGMP, GxP, Health Authority, ISO, and Alcon Quality Manual requirements.
Maintain accurate documentation and complete all required training in accordance with company procedures.
Support the preparation, submission, maintenance, and renewal of state registrations, licenses, permits, and related filings.
Monitor state laws and regulatory requirements to ensure timely submissions and ongoing compliance.
Maintain licensing records and tracking systems to support audits and regulatory inspections.
Communicate with state agencies regarding licensing requirements, submissions, deficiency responses, and information requests.
Partner with Regulatory Affairs, Legal, Compliance, Commercial, and other stakeholders to support licensing activities and compliance inquiries.