Sr Manager QE/QIE

Alcon•Sinking Spring, PA

2d•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. Manager, Quality Assurance is primarily responsible for driving and monitoring quality, technical, and adverse event complaint management for Alcon products. You will ensure compliance with regulations, manage documentation, lead complaint handling teams, and build cross-functional alliances. All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school+15 yrs. Assoc.+11 yrs.; M.S.+4 yrs.; PhD+3 yrs.)
The ability to fluently read, write, understand, and communicate in English
7 Years of Relevant Experience

Nice To Haves

Manage your own workload and schedule while hitting your set targets.
Build positive working relationships to achieve positive goals and business objectives.
Balance experiencing new environments and working autonomously in a remote sales environment.

Responsibilities

Manage and guide teams, implementing departmental plans and ensuring team performance and success
Ensure products and processes meet quality standards and customer requirements
Make decisions affecting team operations and performance, requiring leadership, project management, and problem-solving
Foster a culture of excellence by leading performance management, talent development, and employee engagement
Serve as the focal point for quality-related issues, ensuring compliance with corporate standards and regulatory requirements.
Act as an SME for product quality complaints and Health Authority responses.
Oversee the site escalation process and promote a strong quality culture by collaborating with commercial and regional/global QA Partners on major quality events.
Oversee multiple projects, ensuring goals are met by managing teams and cross-functional projects
Drive implementation of quality assurance strategies, ensuring compliance with industry standards
Support analytical methodology transfers, validations, and quality control analysis on finished products from all sources (R&D, Site to Site, Acquisitions)
Oversee the site change control process ensuring all changes are properly assess for risk and have proper controls to meet process/product/regulatory requirements
Lead large projects and ensure continuous improvement in quality programs and processes including the digital transformation for QA.
Lead High Risk investigations as the responsible quality intelligence engineer.