Assoc. Director, Quality Systems – Vendor Management
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Job Description
Associate Director overseeing Global External Vendor Management program at BioCryst, managing GxP vendor qualifications and lifecycle. Collaborating across multiple groups to ensure compliance and quality.
Responsibilities:
- 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.
Requirements:
- 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.
Benefits:
- Health insurance
- 401(k) matching
- Paid time off
- Professional development opportunities
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