Vertex Pharmaceuticals

Supply Chain

• Work with the GDP Operational QA Management team to ensure medicines are distributed in the USA in compliance with GDP and GMP requirements
• Manage day-to-day Quality oversight of Third Party Logistics providers
• Provide support for key Vertex stakeholders
• Oversee distribution partners within the USA
• Prepare and maintain Quality Agreements
• Review deviations, CAPA, and changes
• Maintain KPIs
• Analyze, resolve, or assist with compliance and customer issues
• Escalate issues
• Perform finished goods release at 3PLs
• Monitor GDP and logistics developments and emerging regulations to guide QMS maintenance
• Lead distribution requirements and expectations for US new product launches
• Collaborate with key internal stakeholders
• Support Clinical QA Distribution
• Maintain the Vertex Pharmaceuticals Incorporated QMS
• Ensure distribution licences accurately reflect the current organization and vary licences when necessary
• Support recalls, mock recalls, and other on-market activities
• Serve as QA assessor/approver on Change Controls, resolving gaps and approving change plans, classifications, and GDP/GMP action strategies
• Support the GDP Management Review process, assess risks from metrics, regulatory intelligence, identified risks, and gaps, and recommend mitigations
• Participate in expansion activities, ensuring Quality actions are planned and completed, including QMS buildout, distribution licence applications, audits, and Quality Agreements
• Plan, prepare, support, and host regulatory inspections
• Provide front- and backroom inspection support
• Follow up post-inspection with responses and CAPAs for continuous improvement
• Report directly to the Senior Manager, Distribution Quality, US

Manager, Distribution Quality – Contract

Compliance

• Support execution of multi-product global regulatory CMC for marketed products
• Prepare and submit regulatory CMC documentation, including clinical trial submissions
• Provide regulatory support to cross-functional teams with a focus on Biologics
• Execute commercial Lifecycle Management strategy and submissions focused on US/Canada/Europe
• Review CMC sections of regulatory submissions and interactions and responses with regulatory agencies
• Develop global regulatory CMC strategies and submissions with regulatory colleagues
• Participate on cross-functional teams
• Serve as the primary regulatory CMC contact for assigned products and projects

Manager, Distribution Quality – Contract

Regulatory CMC Manager