Manager, Quality Assurance Compliance

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Manager, Quality Assurance Compliance supporting the U.S. QA Compliance Team in Fort Worth, TX, a typical day will include:

• Ensure compliance with regulatory requirements and commit to continuous improvement.
• Lead and manage incident management processes for escalations, field action assessments (FAAs), field alert reports (FAR), and market actions to ensure quality-driven oversight and compliance for all Alcon global activities initiated.
• Prepare, assemble, and/or critically review documentation for escalations, FAAs, FARs, market actions, and regulatory responses/reports.
• Monitor and trend escalation, FAA, and market action data for on-going management and review of quality systems.
• Develop strong partnerships with cross-functional stakeholders (Manufacturing sites/Country affiliates, Medical Safety, Regulatory Affairs, Global Supply Chain, DCs, IT, Commercial, etc.) to facilitate compliance processes including maintenance of the Global Compliance Response Team (GCRT) as required for events during non-standard business hours.
• Serve as the process owner of automated incident management system, managing users access levels, identifying system improvements, and performing validations as required.
• Guide and mentor stakeholders to ensure appropriate and timeliness of actions for incident management records.
• Conduct gap assessment of new regulatory standards/guidance’s to identify the impact to Alcon’s standards and systems.
• Lead compliance projects and/or provide informational bulletins to continually improve Alcon’s compliance posture.
• Maintain relevant KPIs and metrics associated with escalation, FAA, and market actions, including development of EMR materials.
• Complete document review for program closures, vendor qualifications, and/or vendor audit CAPA plan management for QA Compliance oversight of Commercial Oriented Marketing Programs (COMP) as required.

What You’Ll Bring To Alcon:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)

• No Travel

• The ability to fluently read, write, understand and communicate in English
• 5 Years of Relevant Experience
• Worksite location: Onsite
• Relocation: No
• Sponsorship Assistance: No
• Knowledge of cGMP regulations for pharmaceutical and medical device manufacturing operations and practices.
• Strong quality mind set and focus with ability to react quickly when required.
• Communicates effectively, strong negotiation, diplomacy, and interpersonal skills.

Preferred:

How You Can Thrive:

• Collaborate with teammates to share standard processes and findings as work evolves
• See your career like never before with focused growth and development opportunities
• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides a robust benefits package including health, life, retirement, flexible time off and much more.

Alcon Careers

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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.