Director, GDP Operational Quality (Hybrid)

Role Summary

The Director, GDP Operational Quality partners with Trade Operations to support the distribution of Vertex’s commercial product portfolio. The role oversees team activities, personnel development, and ensures timely completion and quality of deliverables/goals within their remit. It supports GDP quality operations for all distribution activities within the US; key stakeholders include Trade Operations, Vendor Quality Management & Quality Compliance.

Responsibilities

• Primary quality partner for Vertex US Trade Operations organization, providing quality input and perspective to US Trade Ops continuous improvement initiatives and projects
• Accountable for ensuring US Trade Ops organisation are operating within the Vertex GDP Quality Management System, ensuring deviations are investigated, recorded in the QMS and CAPAs are identified
• Establish robust Quality Processes/Process Ownership for the distribution of Vertex Commercial Finished Goods within the US
• Responsible for local release activities required to support distribution of Vertex Commercial products
• Support Trade Operations with Risk Management activities
• Support the Shipping, Storage & Distribution (SS&D) Process Owners Network (PON). Build, maintain and drive and manage PON activities set out in the SS&D Roadmap
• Responsible for the Quality oversight and management of Vertex strategic US third party logistics providers: creating and maintaining Quality Agreements, developing KPIs, establishing Quality meetings and participating in governance forums
• Support inspection preparation and management, prior to, during and following any Authority inspection; Support manufacturing locations as required
• Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; recommend mitigation approaches
• Participate in New Product Launch activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g., QMS build out, audits, and Quality Agreements
• Act as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions
• Develop, utilize and continue to mature tools to ensure efficiency in execution 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
• Knowledge and demonstrated experience in application of risk-based quality principles in a pharmaceutical environment
• Demonstrated capability to lead a team through organisational change and a dynamic/evolving business model
• Proven leadership ability to design/evolve and implement quality strategies to support commercial and supply chain partners in both clinical and commercial settings
• Strong ability to collaborate cross functionally across all levels of the organization with strong communication skills and the ability to persuade others to adopt a new point of view, achieve consensus and negotiate effectively
• Highly skilled at managing change and driving Continuous Process improvements
• Highly skilled at time and resource management, prioritization of own work and departmental initiatives, and planning/organization skills
• Highly skilled in technical writing
• Demonstrates advanced ability to effectively communicate to local, international and global audiences
• Significant experience in managing/leading others to include performance management and career development
• Strong problem solving and critical thinking skills, accompanied by analytical thinking/data analysis skills
• Demonstrates the Vertex behaviours
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

Skills

• Leadership and people management
• Cross-functional collaboration and stakeholder management
• Quality management systems (QMS) and regulatory compliance
• Risk management and CAPA development
• Change management and continuous improvement
• Technical writing and documentation
• Data analysis and decision making
• Effective communication across local, international, and global teams

Education

• Bachelor's degree in a scientific or allied health field
Typically requires 10 years of relevant work experience, or the equivalent combination of education and experience