Assoc. Director, Quality Systems – Vendor Management

🕒 vor 8 Tagen

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Vollzeit

🔴 Experte

👔 Direktor

Jetzt Bewerben

Ähnliche Remote-Jobs finden

E-Mails für Remote-Jobs erhalten

📊 Überprüfen Sie Ihre Lebenslauf-Bewertung für diese Stelle

Verbessern Sie Ihre Chancen auf ein Vorstellungsgespräch, indem Sie Ihre Lebenslauf-Bewertung vor der Bewerbung überprüfen.

Lebenslauf hochladen

BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAlle Stellen

501 - 1000 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

💰 €450.000.000 Post-IPO Debt - BioCryst Pharmaceuticals im 2023-04

Biotechnology • Pharmaceuticals

BioCryst Pharmaceuticals, Inc. ist ein global tätiges Biotechnologieunternehmen, das sich auf die Entdeckung, Entwicklung und Vermarktung neuartiger oraler kleiner Moleküle und Proteintherapeutika für seltene Krankheiten, insbesondere hereditäres Angioödem (HAE), konzentriert. Seit seiner Gründung im Jahr 1986 nutzt BioCryst strukturgeleitetes Wirkstoffdesign, medizinische Chemie und fortschrittliche Technologien, um erstklassige oder best-in-class Medikamente zu entwickeln, und arbeitet eng mit Patienten, Interessengruppen und globalen Partnern zusammen, um Behandlungen auf den Markt zu bringen.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

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