Title: Senior QA Specialist - Supplier Quality
Location: Onsite, Philadelphia, PA 19112 Schedule: M-F 8am-5pm Type: Direct/Permanent Compensation: Competitive salary with an excellent benefits package Start date: Immediate
Overview:
Join our dynamic team as a QA Specialist - Supplier Quality for a Contract Development and Manufacturing Organization (CDMO) will play a crucial role in ensuring the highest standards of quality and compliance are maintained throughout the cell and gene therapy manufacturing process. The QA Specialist will collaborate with cross-functional teams to implement and maintain robust quality systems, ultimately ensuring the delivery of safe and effective therapies to patients.

Responsibilities:

• Conduct supplier audits and assessments to evaluate and qualify new and existing suppliers.
• Collaborate with cross-functional teams to establish criteria for supplier selection and approval.
• Develop and maintain quality agreements with critical suppliers, outlining expectations and quality standards.
• Ensure adherence to quality agreements by conducting regular reviews and updates as needed.
• Foster strong relationships with suppliers through effective communication and collaboration.
• Act as a liaison between internal teams and suppliers to resolve quality issues and drive improvements.

Requirements:

• BS life sciences
• 5-10 years of experience in QA within biologics, with a focus on maintaining supplier quality program
• Experience establishing quality agreements, performing supplier audits, and managing supplier change notifications
• Experience communicating directly with the FDA, clients, and other external bodies during regulatory inspections and client audits
• Experience conducting internal audits to assess compliance with quality systems and identify areas for improvement.
• Support external audits by regulatory authorities and clients, ensuring a high level of readiness and responsiveness.