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Vertex Pharmaceuticals

Manager, Distribution Quality – Contract

Vertex Pharmaceuticals

. Work with the GDP Operational QA Management team to ensure medicines are distributed in the USA in compliance with GDP and GMP requirements .

Posted 9/23/2026contractBoston • Massachusetts • United StatesMid-LevelSenior💰 $65 - $75 per hourWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in GDP and GMP compliance, with a strong focus on Quality Management Systems (QMS) and risk-based approaches to ensure efficient solutions. Capable of leading cross-functional collaborations and managing regulatory inspections while maintaining high standards of quality oversight.

Highest-signal resume keywords
Bachelor's Degree in Scientific or Allied Health FieldStrong Knowledge of International GDP RegulationsGood Knowledge of GMP RegulationsAbility to Apply Risk-Based ApproachesLeadership Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Quality Management Systems (QMS)Deviation ReviewCAPA ManagementKPI MaintenanceFinished Goods ReleaseRegulatory Inspection SupportChange Control AssessmentRisk Mitigation Strategy DevelopmentDistribution License ManagementQuality Agreement Preparation
Soft Skills
CollaborationEffective CommunicationCritical ThinkingStrategic ThinkingTime Management
Industry Keywords
Good Distribution Practice (GDP)Good Manufacturing Practice (GMP)ICH Q9Regulatory ComplianceThird Party Logistics (3PL)Quality OversightClinical QA DistributionMock RecallsRisk AssessmentQuality Actions

About the role

Key responsibilities & impact
  • 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

Requirements

What you’ll need
  • Bachelor’s degree in a scientific or allied health field
  • Strong knowledge of international GDP regulations
  • Good knowledge of GMP regulations
  • Good understanding of ICH Q9
  • Ability to apply risk-based approaches to lead and develop efficient solutions balancing compliance and business requirements
  • Ability to proactively identify risk and develop mitigation strategies
  • Ability to collaborate cross-functionally and influence others through active listening and articulate, convincing ideas
  • Ability to adapt activities to embrace change and support business growth and process improvements
  • Ability to communicate effectively with local, international, and global audiences with integrity
  • Critical and strategic thinking to determine and mitigate complex challenges and impacts
  • Business acumen and leadership skills
  • Time and resource management skills

Benefits

Comp & perks
  • Overtime pay in accordance with federal and state requirements
  • Compensation and medical benefits, fringe benefits, and other employment terms presented by the third-party agency partner upon offer
  • Temporary role through a third-party agency partner