Assoc. Director, Quality Systems (Vendor Mgmt)
BioCryst Pharmaceuticals, Inc.
7 days ago
Remote friendly (North Carolina, United States)
United States
Operations
Job Summary
The Associate Director, Quality Systems will oversee the Global External Vendor Management program for all BioCryst GxP outsourced activities (GCP, GLP, GMP, GDP, GVP) across the lifecycle of clinical and commercial products, including new vendor qualification and ongoing vendor lifecycle management. Reports to VP, Global Quality Assurance with close coordination across Pharmaceutical Development, QA, QC, Clinical, Regulatory, IT, Supply Chain, and Finance.
Essential Duties & Responsibilities
- Oversee initial qualification and continued QA management of external GxP vendors for starting/raw materials, API, drug product/finished drug product, and medical devices; includes clinical and/or post-marketing safety service vendors.
- Develop and maintain the Vendor Qualification Program (annual audit plans); coordinate/conduct audits; communicate results; track action items to closure.
- Implement and manage QA agreements for external vendors; ensure creation, review, adherence, and role/requirement clarity.
- Enhance/maintain the approved vendor list; oversee vendor change assessments and associated internal controls.
- Support operational excellence strategies internally and at external vendors.
- Identify quality system improvements using risk-based methodologies; oversee vendor corrective actions and escalation/resolution of critical/major issues.
- Assess internal/external GxP readiness for Health Authority inspections; support cross-functional quality system audits.
- Serve as GxP vendor management SME for process improvement.
- Maintain knowledge of FDA/EU/ICH and country-specific regulations; assess vendor KPIs/metrics and apply Quality Risk Management techniques.
- Lead the QA Vendor Management team; develop training curriculum, ensure team training, and mentor; support other QA activities as assigned.
Experience & Qualifications
- BS/BA required (technical discipline preferred).
- 10+ years pharmaceutical QA Operations/related; 5+ years in vendor management/project management including external vendor auditing. ASQ or other auditing certification a plus.
- Thorough knowledge of global cGMP requirements for clinical/commercial API, drug products, and medical devices.
- Inspection management experience (FDA/EMEA/JMDA) highly desirable.
- Strong risk management fundamentals/tools.
- Intermediate–advanced software skills (Excel, PowerPoint, Microsoft Project).
- Travel up to 40% (potential international).
- Excellent organizational, attention to detail, communication/negotiation/presentation, and cross-functional/remote work capabilities.
The Associate Director, Quality Systems will oversee the Global External Vendor Management program for all BioCryst GxP outsourced activities (GCP, GLP, GMP, GDP, GVP) across the lifecycle of clinical and commercial products, including new vendor qualification and ongoing vendor lifecycle management. Reports to VP, Global Quality Assurance with close coordination across Pharmaceutical Development, QA, QC, Clinical, Regulatory, IT, Supply Chain, and Finance.
Essential Duties & Responsibilities
- Oversee initial qualification and continued QA management of external GxP vendors for starting/raw materials, API, drug product/finished drug product, and medical devices; includes clinical and/or post-marketing safety service vendors.
- Develop and maintain the Vendor Qualification Program (annual audit plans); coordinate/conduct audits; communicate results; track action items to closure.
- Implement and manage QA agreements for external vendors; ensure creation, review, adherence, and role/requirement clarity.
- Enhance/maintain the approved vendor list; oversee vendor change assessments and associated internal controls.
- Support operational excellence strategies internally and at external vendors.
- Identify quality system improvements using risk-based methodologies; oversee vendor corrective actions and escalation/resolution of critical/major issues.
- Assess internal/external GxP readiness for Health Authority inspections; support cross-functional quality system audits.
- Serve as GxP vendor management SME for process improvement.
- Maintain knowledge of FDA/EU/ICH and country-specific regulations; assess vendor KPIs/metrics and apply Quality Risk Management techniques.
- Lead the QA Vendor Management team; develop training curriculum, ensure team training, and mentor; support other QA activities as assigned.
Experience & Qualifications
- BS/BA required (technical discipline preferred).
- 10+ years pharmaceutical QA Operations/related; 5+ years in vendor management/project management including external vendor auditing. ASQ or other auditing certification a plus.
- Thorough knowledge of global cGMP requirements for clinical/commercial API, drug products, and medical devices.
- Inspection management experience (FDA/EMEA/JMDA) highly desirable.
- Strong risk management fundamentals/tools.
- Intermediate–advanced software skills (Excel, PowerPoint, Microsoft Project).
- Travel up to 40% (potential international).
- Excellent organizational, attention to detail, communication/negotiation/presentation, and cross-functional/remote work capabilities.