Distribution Quality Lead - GDP/GMP Compliance

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 90,000 - 103,000; Full time

Job summary

Vertex Pharmaceuticals LLC in the U.S. state of Massachusetts seeks a Manager to oversee GDP and GMP compliance for distribution activities.

You will manage day-to-day quality oversight of third-party logistics partners and support stakeholders across Vertex in distribution quality. The role reports to the Senior Manager, Distribution Quality, US and requires collaboration with cross-functional teams to ensure compliant product launches and ongoing quality improvement.

Qualifications

• Bachelor’s degree in a scientific or allied health field.
• Strong knowledge of GDP regulations and GMP compliance.
• Experience leading quality oversight of third-party logistics providers.
• Ability to drive risk-based quality decisions.

Responsibilities

• Provide day-to-day quality oversight of 3PLs in the USA.
• Prepare and maintain Quality Agreements; review deviations, CAPA, and changes.
• Maintain KPIs and analyze regulatory and customer-related issues.
• Escalate issues as required and support recalls and incidents.
• Lead change controls and participate in GDP/GMP-related QMS initiatives.
• Support Regulatory inspections and post-inspection CAPAs.

Skills

GDP knowledge

GMP knowledge

ICH Q9

Risk mitigation

Cross-functional collaboration

Regulatory inspections

Education

Bachelor’s degree in a scientific or allied health field

Job description

Vertex Pharmaceuticals LLC in the U.S. state of Massachusetts seeks a Manager to oversee GDP and GMP compliance for distribution activities.

You will manage day-to-day quality oversight of third-party logistics partners and support stakeholders across Vertex in distribution quality. The role reports to the Senior Manager, Distribution Quality, US and requires collaboration with cross-functional teams to ensure compliant product launches and ongoing quality improvement.