What are the responsibilities and job description for the Manger, Quality Assurance position at W3Global Inc.?
Job Description
Job Description
Job Title : Quality Assurance (QA) Manager
Department : Quality & Regulatory Affairs
Location : TarryTown, NY
Job Summary
The Quality Assurance (QA) Manager plays a critical role in the Quality & Regulatory Affairs Department, supporting both existing and new sterile eyecare products. This individual ensures compliance with aseptic processing standards and oversees the sterile manufacturing processes of third-party contract manufacturers (Contractors). The QA Manager will develop and execute Quality Assurance programs while collaborating closely with internal stakeholders, including Regulatory Affairs, Medical Affairs, Strategic Sourcing, New Product Development, Package Development, Supply Planning, and Logistics.
Key Responsibilities
Foster strong relationships across the organization to uphold quality and aseptic processing standards.
Act as the primary Quality contact for assigned sterile eyecare brands and / or Contractors.
Influence QA strategy by analyzing product requirements, validating stability and process performance, and recommending corrective action plans.
Support new product introductions by reviewing and approving documentation such as aseptic processing protocols, stability protocols, laboratory methods, master batch records, product specifications, and validation reports.
Ensure Contractor compliance through effective audits, assessment of quality systems, and corrective actions where necessary.
Negotiate, prepare, and review Quality Agreements to define Contractor obligations and responsibilities.
Monitor commercial product quality by overseeing change controls, deviations, nonconformances, and out-of-specification investigations.
Prepare regulatory and compliance reports, including Stability, Complaints, Nonconformance Reports, Deviations, Investigations, CAPAs, and Annual Product Reviews.
Stay informed of national and international regulatory developments related to sterile ophthalmics and aseptic processing through continuous learning and professional engagement.
Drive continuous improvement initiatives and explore opportunities to enhance job performance and organizational goals.
Qualifications & Experience
Bachelor's degree in a Scientific discipline (Microbiology preferred).
Minimum of 5 years of QA experience in aseptic processing with a strong understanding of Quality Systems, Quality Assurance, and Quality Control.
Experience participating in audits and ensuring compliance with regulatory requirements.
Strong decision-making and scientific problem-solving skills based on risk management principles.
Ability to manage multiple responsibilities with a high sense of urgency.
Proficiency in SAP or similar ERP systems and knowledge of IT validations in a GMP environment.
Strong analytical skills with the ability to interpret data and drive corrective actions.
Excellent verbal and written communication skills with demonstrated interpersonal effectiveness.
High proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Project).
Additional Information
This role requires up to 25% travel for site visits, audits, and meetings with Contractors.
The QA Manager must ensure the confidentiality of organizational and regulatory information.
To Apply : Please submit your resume and cover letter to [Insert Application Details].
