Manager, Quality Assurance - Remote

Overview

The Quality Assurance (QA) Manager will hold a key position in our Quality & Regulatory Affairs Department, supporting existing products and new product introductions in sterile eyecare by providing and applying Quality Assurance and aseptic processing.

In Short

• Foster close cooperative relationships with all functions in the company relative to quality and aseptic processing.
• Act as the point of contact for Quality matters for assigned sterile eyecare brands and/or Contractors.
• Influence QA strategy for assigned brands by studying product requirements and analyzing options.
• Support new product introductions from a Quality perspective.
• Evaluate the effectiveness of Contractors’ quality systems through audits.
• Define quality obligations and responsibilities of Contractors.
• Assure the quality of commercial products by reviewing and approving Contractors’ change controls.
• Prepare reports by collecting, analyzing, and summarizing regulatory and compliance data.
• Protect organization’s competitiveness by keeping information confidential.
• Learn national and international regulatory developments related to sterile ophthalmics.

Requirements

• Minimum of BS in a Scientific discipline, microbiology preferred.
• 5 years QA experience in aseptic processing.
• Experience with participating in audits.
• Demonstrated sound decision-making and scientific problem-solving capabilities.
• Proven track record of managing multiple responsibilities.
• Experience with SAP or similar ERP systems.
• Knowledge of IT validations to support a GMP environment.
• Ability to lead a project and work independently.
• Outstanding verbal and written communication skills.
• High proficiency in computer skills, Microsoft Office/Project.

Benefits

• Hybrid work schedule with remote work options.
• Competitive salary range.
• Opportunity to work in a leading healthcare company.
• Professional development opportunities.
• Collaborative work environment.