Assoc. Director, Quality Systems (Vendor Mgmt)
BioCryst Pharmaceuticals, Inc.
2 months ago
Remote friendly (North Carolina, United States)
United States
Operations
Essential Duties & Responsibilities
- Oversee initial qualification and ongoing QA management of external GxP vendors for outsourced activities across the lifecycle of Starting Materials, Raw Materials, API, Drug Product, Finished Drug Product, and medical device; also oversee clinical and/or post-marketing safety service vendors.
- Develop and maintain the Vendor Qualification Program, including annual audit plans; coordinate/conduct audits; communicate results; track audit action items to closure.
- Support implementation/management of Quality Assurance agreements for external vendors, ensuring creation/maintenance, periodic review, and defined roles and responsibilities.
- Enhance and maintain the approved vendor list.
- Oversee assessment of vendor reported changes and associated internal vendor change controls.
- Support deployment of operational excellence strategies internally and at external GxP vendors.
- Identify quality system improvements using risk-based methodologies to improve compliance and efficiency.
- Ensure oversight of vendor corrective actions and escalation/resolution of critical/major issues within timelines.
- Assess and support internal/external GxP vendor readiness for Health Authority inspections (PAI, routine, directed, other).
- Support internal cross-functional Quality System audits.
- Serve as SME for GxP vendor management process improvement activities.
- Maintain up-to-date knowledge of FDA/EU/ICH and country-specific regulations and relevant guidance.
- Assess vendor KPIs/metrics/process performance indicators/quality system signals; apply Quality Risk Management techniques.
- Lead the QA Vendor Management team; develop team training curriculum, ensure training, and provide mentoring.
Experience & Qualifications
- BS/BA required (technical discipline preferred).
- 10+ years pharmaceutical QA Operations (or relevant) with 5 years in vendor management/project management, including auditing external vendors; ASQ or other auditing certifications a plus.
- Thorough knowledge of global cGMP requirements for clinical and commercial operations for API and drug products & medical devices.
- Inspection management experience (e.g., FDA, EMEA, JMDA) highly desirable.
- Strong risk management fundamentals/tools understanding.
- Intermediate to advanced software skills (e.g., Excel, PowerPoint, Microsoft Project).
- Travel up to 40% (potential international).
- Excellent organizational, communication, negotiation, presentation, attention to detail, and cross-functional leadership/problem-solving skills.
- Ability to work effectively in cross-functional teams and independently (including remote work).
- Oversee initial qualification and ongoing QA management of external GxP vendors for outsourced activities across the lifecycle of Starting Materials, Raw Materials, API, Drug Product, Finished Drug Product, and medical device; also oversee clinical and/or post-marketing safety service vendors.
- Develop and maintain the Vendor Qualification Program, including annual audit plans; coordinate/conduct audits; communicate results; track audit action items to closure.
- Support implementation/management of Quality Assurance agreements for external vendors, ensuring creation/maintenance, periodic review, and defined roles and responsibilities.
- Enhance and maintain the approved vendor list.
- Oversee assessment of vendor reported changes and associated internal vendor change controls.
- Support deployment of operational excellence strategies internally and at external GxP vendors.
- Identify quality system improvements using risk-based methodologies to improve compliance and efficiency.
- Ensure oversight of vendor corrective actions and escalation/resolution of critical/major issues within timelines.
- Assess and support internal/external GxP vendor readiness for Health Authority inspections (PAI, routine, directed, other).
- Support internal cross-functional Quality System audits.
- Serve as SME for GxP vendor management process improvement activities.
- Maintain up-to-date knowledge of FDA/EU/ICH and country-specific regulations and relevant guidance.
- Assess vendor KPIs/metrics/process performance indicators/quality system signals; apply Quality Risk Management techniques.
- Lead the QA Vendor Management team; develop team training curriculum, ensure training, and provide mentoring.
Experience & Qualifications
- BS/BA required (technical discipline preferred).
- 10+ years pharmaceutical QA Operations (or relevant) with 5 years in vendor management/project management, including auditing external vendors; ASQ or other auditing certifications a plus.
- Thorough knowledge of global cGMP requirements for clinical and commercial operations for API and drug products & medical devices.
- Inspection management experience (e.g., FDA, EMEA, JMDA) highly desirable.
- Strong risk management fundamentals/tools understanding.
- Intermediate to advanced software skills (e.g., Excel, PowerPoint, Microsoft Project).
- Travel up to 40% (potential international).
- Excellent organizational, communication, negotiation, presentation, attention to detail, and cross-functional leadership/problem-solving skills.
- Ability to work effectively in cross-functional teams and independently (including remote work).