Sr. Associate, Quality Assurance Compliance – US Distribution Quality

Alcon MX; Fort Worth (TX); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Flexible time off

Life insurance

Job summary

Alcon in Fort Worth, TX is seeking a Sr. Associate, Quality Assurance Compliance – US Distribution Quality to provide tactical site support ensuring compliance with site, Alcon, and international regulations.

You will coordinate site gap assessments and apply advanced knowledge to achieve objectives, working at our Fort Worth facility. The role requires knowledge of cGMP, GxP, ISO standards, and strong analytical skills.

Qualifications

• Support harmonization 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 site gap assessments and support implementation of corrective actions to maintain compliance.

Responsibilities

• State Licensing & Regulatory Support: prepare, submit, maintain, and renew state registrations, licenses, and permits; monitor regulatory requirements and ensure timely submissions.

Skills

Quality Assurance

Regulatory Compliance

cGMP / GxP

ISO standards

Regulatory submissions

Analytical skills

Documentation

Attention to detail

Education

Bachelor's Degree

Job description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?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**. Specifics include: **Quality Management System & Compliance*** 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. **State Licensing & Regulatory Support*** 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.* 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. **WHAT YOU’LL BRING TO ALCON:*** 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* **Work Hours:** Monday – Friday, 8:00 AM – 5:00 PM CST* **Location**: Onsite* **Travel Requirements**: Up to 10%* **Relocation Assistance**: None* **Sponsorship Available**: NO **HOW YOU CAN THRIVE AT ALCON:*** Collaborate with teammates to share standard processes and learnings as work evolves!* Join Alcon’s mission to provide top-tier, innovative products and solutions to enhance sight & enhance lives.* Grow your career in a highly collaborative and diverse environment.* Alcon provides robust benefits package including health, life, retirement, flexible time off for salaried associates, paid time off for hourly associates and much more!