Assoc. Director, Quality Systems – Vendor Management

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Manage the Global External Vendor Management program for all BioCryst GxP outsourced operations, encompassing GCP, GLP, GMP, GDP, and GVP vendors.

• Oversee all new vendor qualification processes and the ongoing management of the vendor lifecycle.

• Ensure comprehensive oversight of the initial qualification and continuous quality assurance management of external GxP vendors.

• Create and uphold the Vendor Qualification Program, which includes annual audit strategies and the coordination and/or execution of audits.

• Assist in the implementation and management of Quality Assurance agreements for external vendors.

• Improve and maintain the approved vendor list.

• Supervise the assessment of vendor-reported changes and related internal vendor change controls.

• Facilitate the deployment of operational excellence strategies both internally and at external GxP vendors.

• Identify quality enhancements for BioCryst Quality Systems.

• Ensure oversight of vendor corrective actions to address quality and technical issues identified for all GxP vendors.

• Ensure that critical and major issues are escalated according to standard procedures to management and addressed within designated timelines.

• Evaluate and support the readiness of Internal and External GxP vendors for Health Authority inspections.

• Assist with Internal cross-functional Quality System audits.

⛳️ Requirements

• A BS/BA degree is required, preferably in a technical discipline.

• At least ten (10) years of experience in the pharmaceutical industry in QA Operations or other relevant operational fields, including a minimum of five (5) years focused on vendor management, project management, and auditing of external vendors.

• ASQ or other auditing certifications are advantageous.

• Extensive knowledge of global cGMP standards (FDA, EU, ICH & specific country regulations and other pertinent guidelines governing GxP activities) for clinical and commercial operations pertaining to API, Drug Products, and Medical Devices.

• Prior experience with inspection management, including interactions with FDA, EMEA, JMDA, and similar organizations, is highly preferred.

• Strong grasp and ability to apply risk management fundamentals and tools.

• Intermediate to advanced proficiency in software applications (e.g., Microsoft Excel, PowerPoint, Microsoft Project).

• Must be capable and willing to travel (up to 40%) as necessary, including potential international travel.

• Excellent organizational skills with the ability to manage multiple projects under tight deadlines are essential.

• Strong attention to detail and a commitment to accuracy in information.

• Exceptional communication, negotiation, and presentation skills; upholds high ethical standards, enjoys collaboration with people and information, and has a knack for decision-making and problem-solving in a leadership capacity.

• Proven ability to operate effectively in a cross-functional team environment and independently in a remote work setting when required.

• Strong problem-solving and decision-making capabilities.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Paid time off

• Professional development opportunities