Assoc. Director, Quality Systems; Vendor Mgmt

COMPANY

At Bio Cryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure‑guided drug design to develop first‑in‑class or best‑in‑class oral small‑molecule and injectable protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama.

Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries.

Associate Director, Quality Systems will oversee the Global External Vendor Management program for all Bio Cryst GxP outsourced activities, including GCP, GLP, GMP, GDP, and GVP vendors being utilized by Bio Cryst throughout the lifecycle of all Clinical and Commercial Products. The Associate Director will be responsible for oversight of all new vendor qualification activities and ongoing vendor lifecycle management. This role reports directly to the VP, Global Quality Assurance but has high visibility throughout the organization and therefore requires close coordination across multiple groups within Bio Cryst, e.g., Pharmaceutical Development, QA, QC, Clinical, Regulatory, IT, Supply Chain and Finance.

• In collaboration with other QA team members, ensure oversight of the initial qualification and continued QA management of external GxP vendors involved in the development and commercial manufacturing, testing, packaging, labeling, storage, and distribution of Starting Materials, Raw Materials, API, Drug Product and Finished Drug Product and medical device. Vendor Management also applies to external vendors providing clinical and/or Post Marketing safety services to Bio Cryst.
• Develop and maintain the Vendor Qualification Program including annual audit plans, coordinating and/or conducting audits in accordance with established GxP goals and objectives; communicate audit results to Management and stakeholders and track vendor audit action items to closure.
• Support implementation and management of Quality Assurance agreements for external vendors, ensuring they are created and maintained according to company requirements, that they are regularly reviewed and followed, and that they address the respective roles, responsibilities and requirements for all parties involved.
• 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 Bio Cryst Quality Systems to maintain compliance and improve efficiency utilizing risk‑based methodologies, as related to vendor management/vendor oversight.
• In collaboration with other QA team members, ensures oversight of vendor corrective actions to ensure the resolution of quality and technical problems identified for all GxP vendors.
• In collaboration with other QA team members, ensures that the all‑critical and major issues, which may have an adverse effect on the quality of the product, 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 (PAI, routine, directed, other).
• Support Internal cross functional Quality System audits.
• Support Bio Cryst process improvement activities as a subject matter expert (SME) in GxP vendor management.
• Maintain up‑to‑date knowledge of FDA, EU, ICH & country specific regulations and other relevant guidance governing GxP activities.
• Supports assessment of vendor quality KPI's, metrics, process performance indicators and quality system signals for adequacy of performance during periodic vendor performance management reviews. Deploy Quality Risk Management Techniques for quality oversight and problem resolution for oversight of external vendors.
• Leads the QA Vendor Management team who may be delegated to perform any of the activities listed above.
• Develops Vendor Management…