Director, GDP Operational Quality (Hybrid)

Role Summary

Director, GDP Operational Quality responsible for partnering with Trade Operations to support Vertex’s distribution of its commercial product portfolio in the US. Oversees team activities, personnel development, and delivery quality, ensuring timely completion of deliverables within scope.

Responsibilities

• Primary quality partner for Vertex US Trade Operations, providing input to continuous improvement initiatives and projects.
• Ensure US Trade Ops operates within the Vertex GDP Quality Management System; investigate deviations, record in QMS, and identify CAPAs.
• Establish robust Quality Processes/Process Ownership for distribution of Vertex Commercial Finished Goods in the US.
• Responsible for local release activities required to support distribution of Vertex Commercial products.
• Support Trade Operations with Risk Management activities.
• Support SS&D Process Owners Network (PON); build, maintain, and drive PON activities per the SS&D Roadmap.
• Quality oversight and management of Vertex strategic US third-party logistics providers: creating/maintaining Quality Agreements, developing KPIs, establishing Quality meetings, and governance participation.
• Support inspection preparation and management before/during/after Authority inspections; support manufacturing locations as required.
• Support GDP Management Review process; assess risks from metrics, regulatory intelligence, and identified risks/gaps; recommend mitigations.
• Participate in New Product Launch activities to ensure Quality actions are planned and completed (QMS build-out, audits, Quality Agreements).
• Act as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, and GDP/GMP action strategies.
• Develop and mature tools to improve efficiency of Distribution Quality Processes.

Qualifications

• GDP & GMP work experience or relevant comparable background.
• Expert knowledge of International GDP regulations; broad knowledge of GMP and GVP regulations.
• Experience applying risk-based quality principles in a pharmaceutical environment.
• Ability to lead a team through organizational change and a dynamic business model.
• Proven leadership to design/evolve and implement quality strategies for commercial and supply chain partners.
• Strong cross-functional collaboration, with excellent communication, persuasion, consensus-building, and negotiation skills.
• Change management and continuous process improvement capabilities.
• Time and resource management, prioritization, planning, and organizational skills.
• Technical writing proficiency; effective communication to local, international, and global audiences.
• Experience managing/leading others, including performance management and career development.
• Analytical thinking and data analysis skills for sound decision-making.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).

Education

• Bachelor‚Äôs degree in a scientific or allied health field.
• Typically requires 10 years of relevant work experience, or equivalent combination of education and experience.