Associate Director, Quality Assurance

Job not on LinkedIn

🔥 20 hours ago

🐎 Kentucky, New Hampshire, +11 more states – Remote

🐎 Kentucky – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🌶️ New Mexico – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote 🎸 Mississippi – Remote 🔔 Pennsylvania – Remote 🌴 South Carolina – Remote 🗿 South Dakota – Remote 🤠 Texas – Remote ☕ Washington – Remote

💵 $176k - $204k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Aurion Biotech

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2022

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 $120M Venture Round - Aurion Biotechnologies on 2022-04

Healthcare • Manufacturing • Biotechnology

Aurion Biotech is a clinical-stage company developing first-in-class regenerative cell therapies to restore vision by treating corneal endothelial disease and other causes of blindness. The company focuses on manufacturing-scale cell therapy platforms, using human donor corneal endothelial cells combined with supportive compounds (e. g. , rho-kinase inhibitor) to repopulate the corneal endothelium, reduce reliance on donor tissue, and enable less-invasive alternatives to graft-based keratoplasty. Aurion conducts global clinical trials, holds FDA Breakthrough Therapy and RMAT designations for its lead product AURN001, and aims to expand access to advanced ophthalmic care worldwide.

📋 Description

• Serve as team lead to internal QA team members • Lead QA oversight of CDMO and internal QA activities, ensuring compliance with regulatory/GMP expectations and established Quality Agreements • Support and maintain vendor assessment activities • Provide quality management of vendors using risk-based decision-making during manufacturing and testing activities • Support quality performance and continuous improvement activities • Oversee quality of third-party supplier services, including manufacturing, filling, packaging, and shipping as appropriate • Maintain regular oversight through periodic monitoring, auditing, and Quality Agreement reviews • Manage Data Verification activities to ensure data integrity and compliance with GDP • Identify opportunities to improve quality systems and clinical-to-commercial operational processes and drive implementation to completion • Develop, monitor, and report quality metrics and KPIs to support Quality Management Review • Support quality systems, including internal and external deviations and change controls • Assess product, compliance, and operational risks and partner with cross-functional teams to develop and implement risk management strategies • Review and approve controlled documents • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree in Biology, Chemistry or other relevant scientific discipline preferred • 8-10 years of cGMP Quality Assurance experience with cell therapy, biologics, and/or small molecule programs • 5+ years of experience directly managing a team of direct reports within QA • Commercial QA experience a plus • Travel required up to 35% • Experience with eQMS (e.g., ACE, TrackWise) • Working knowledge of current industry practices and standards in an FDA-regulated biotechnology company • Excellent record keeping and documentation skills • Strong verbal and written communication skills, with the ability to concisely present information in cross-functional settings • Experience working with CDMOs preferred • Proficient use of MS Office products • Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and a great sense of urgency while ensuring that all cGMP and regulatory requirements are met • Ability to work effectively both independently and with other team members

🏖️ Benefits

• Full health insurance for employees and their families • 401(k) matching • EAP • FSA • Generous PTO • Paid parking • Subsidized commuter passes • In-office catered lunches • Team events • Community projects • Competitive compensation packages