Director, Quality Assurance Compliance

Alcon•Fort Worth, TX

19h•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 Director, Quality Assurance Compliance (Professional Path), is primarily responsible for providing Global Quality Compliance direction to Business Unit(s), local sites, and others as needed to establish and implement practices and procedures that comply with applicable regulations, current industry and regulatory guidelines, and Alcon global standards.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)
The ability to fluently read, write, understand and communicate in English
10 Years of Relevant Experience

Nice To Haves

People and project management experience
Experience in medical device or pharmaceutical industries
Relevant work experience in a lab

Responsibilities

Coordinate and manage to close Field Action Assessments and market actions.
Review escalations for immediate action and follow up.
Provides compliance guidance to critical investigations (e.g., non-conformance, OOS, deviation, complaints, etc.) to ensure that issues or events are escalated as required, reporting requirements to regulatory authorities are met, and that investigation, analysis, corrective/preventive actions, and documentation are comprehensive and timely.
Coordinate and review responses to Health Authority observations and queries/reporting regarding market actions.
Coordinate Compliance Alert analysis with manufacturing sites and prepare Divisional summaries for approval and submission to Alcon.
Prepare and present regulatory and Lessons Learned Information via Compliance Forums.
Review and assess new / revised industry and regulatory standards for Division impact.
Provide strategic expertise and direction, influencing multiple projects and overall business outcomes
Lead Quality Systems Management, Complaints Management, and Supplier Quality Management processes to ensure compliance with current Good Manufacturing Practices (cGMP), Health Authority, Alcon Quality Manual, and International Organization for Standardization (ISO) standards
Facilitate the implementation of the Quality Strategy and support governance processes
Identify opportunities for improved process efficiencies and implement changes
Define and report the performance of the Quality organization
Own and maintain Quality systems
Support Quality projects and strategic initiatives
Make significant decisions within projects, requiring strategic planning and advanced industry knowledge