Sr Manager QE/QIE

Alcon MX; Sinking Spring (Berks County); On-site; USD 130,000 - 165,000; Full time

Job summary

Alcon is seeking a Sr. Manager, Quality Assurance for our Sinking Spring site. This onsite role leads quality, regulatory affairs, and adverse event management to ensure product compliance and patient safety.

You will build cross-functional alliances, guide investigations, and drive continuous improvement in QA programs, including digital transformations and high-risk investigations. Bachelor’s degree plus extensive experience required; English fluency mandatory.

Qualifications

• Bachelor’s Degree or equivalent years of directly related experience.
• The ability to fluently read, write, understand, and communicate in English.
• 7 Years of Relevant Experience

Responsibilities

• Lead and guide QA teams, implementing departmental plans and ensuring team performance.
• Ensure products and processes meet quality standards and regulatory requirements.
• Act as SME for product quality complaints and Health Authority responses.
• Oversee site change control, risk assessments, and regulatory compliance of changes.
• Drive continuous improvement in QA programs and lead large cross-functional projects.

Education

Bachelor’s Degree or Equivalent years of directly related experience

Job description

This is an onsite position based out of our Sinking Springs Location 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.

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.

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.

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.

Key Requirements / Minimum Qualifications

• 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

Preferred Qualifications

How to Thrive at Alcon:

• 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.

Benefits

• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, and much more!

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 [e-mail] and let us know the nature of your request and your contact information.

At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.