Assoc. Director, Quality Systems (Vendor Mgmt)

COMPANY:

At BioCryst, 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 and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com  or follow us on LinkedIn and Instagram.

JOB SUMMARY:

The Associate Director, Quality Systems will oversee the Global External Vendor Management program for all BioCryst GxP outsourced activities, including GCP, GLP, GMP, GDP, and GVP vendors being utilized by BioCryst 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 BioCryst, e.g., Pharmaceutical Development, QA, QC, Clinical, Regulatory, IT, Supply Chain and Finance. 

ESSENTIAL DUTIES & RESPONSIBILITIES:

• 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 BioCryst.
• 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 BioCryst 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 BioCryst 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 Team training curriculum, ensures team is trained, and provides mentoring to the team. Provides support and contributes to other Quality Assurance activities as assigned.

EXPERIENCE & QUALIFICATIONS:

• 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.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.