Assoc. Director, Quality Systems – Vendor Management

🕒 Maio 31

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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BioCryst Pharmaceuticals, Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

🧬 Biotecnologia

💊 Farmacêutico

💰 $450.000.000 Post-IPO Debt - BioCryst Pharmaceuticals em 2023-04

Biotechnology • Pharmaceuticals

A BioCryst Pharmaceuticals, Inc. é uma empresa global de biotecnologia focada na descoberta, desenvolvimento e comercialização de novos tratamentos orais com pequenas moléculas e proteínas para doenças raras, notadamente o angioedema hereditário (AEH). Fundada em 1986, a BioCryst utiliza design de medicamentos guiado por estrutura, química medicinal e tecnologias avançadas para desenvolver medicamentos de primeira classe ou superiores, e trabalha em estreita colaboração com pacientes, grupos de apoio e parceiros globais para levar os tratamentos ao mercado.

Descrição

• Oversee the Global External Vendor Management program for all BioCryst GxP outsourced activities, including GCP, GLP, GMP, GDP, and GVP vendors. • Responsible for oversight of all new vendor qualification activities and ongoing vendor lifecycle management. • Ensure oversight of the initial qualification and continued QA management of external GxP vendors. • Develop and maintain the Vendor Qualification Program including annual audit plans, coordinating and/or conducting audits. • Support implementation and management of Quality Assurance agreements for external vendors. • Enhance and maintain the approved vendor list. • Oversee assessment of vendor reported changes and associated internal vendor change controls. • Supports deployment of operational excellence strategies internally and at external GxP vendors. • Identifies quality improvements to BioCryst Quality Systems. • Ensures oversight of vendor corrective actions to resolve quality and technical problems identified for all GxP vendors. • Ensures that critical and major issues are escalated as per standard procedures to management and are resolved within stated timelines. • Assesses and supports Internal and External GxP vendor readiness for Health Authority inspections. • Support Internal cross functional Quality System audits.

🎯 Requisitos

• BS/BA Degree required with a degree in a technical discipline preferred. • Minimum of ten (10) years of pharmaceutical experience in QA Operations and/or other relevant operational areas but should include five (5) years in vendor management, project management, including auditing of external vendors. • ASQ or other auditing certifications are a plus. • Thorough knowledge of global cGMP requirements (FDA, EU, ICH & country specific regulations and other relevant guidance governing GxP activities) for clinical and commercial operations for API and Drug Products & Medical Devices. • Previous experience with inspection management including FDA, EMEA, JMDA, and others is highly desirable. • Strong understanding and ability to implement risk management fundamentals/tools. • Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, Microsoft Project). • Must be capable and willing to travel (up to 40%) as required, with potential for international travel. • Excellent organizational skills and ability to work on multiple projects with competitive timelines is required. • Strong attention to detail and respect for the need of accuracy of information. • Excellent communication, negotiation, and presentation skills; maintains high ethical standards, and enjoys working with people and information, making decisions, problem solving, making a difference and working in a leadership role. • Demonstrated ability to work effectively in cross functional team environment and independently in a remote work setting, as necessary. • Excellent problem-solving and decision-making skills.

🏖️ Benefícios

• Health insurance • 401(k) matching • Paid time off • Professional development opportunities