Senior GMP Quality & Compliance Lead

Vertex Pharmaceuticals LLC; Boston (MA); In loco; USD 90.000 - 96.000; Tempo pieno

Descrizione del lavoro

Vertex Pharmaceuticals LLC is seeking a GMP Operational Quality Senior Specialist Contractor to support quality assurance and regulatory compliance across Vertex and contracted suppliers. The role focuses on investigations, CAPA, change control, and timely batch release.

The candidate will lead quality metrics, root-cause analysis, and risk mitigation within a fast-paced pharmaceutical environment, reporting to the Senior Manager, GMP Operational Quality.

Competenze

• Bachelor's degree in scientific or allied health field (or equivalent degree).
• Typically requires 3 years of experience in Quality support and oversight of GMP manufacturing operations.
• Experience with drug substance and drug product development/manufacturing in a pharmaceutical setting; knowledge of cGMPs.

Mansioni

• Provide quality oversight for manufacturing operations within Vertex or contracted suppliers.
• Support change control procedures and CAPA actions with timely closure.
• Lead or support investigations, deviations, OOS/OOT with root-cause analysis and product impact assessments.
• Maintain Quality Metrics and ensure on-time batch release and risk mitigation.

Conoscenze

Quality Assurance

GMP

CAPA

Root Cause Analysis

Cross-functional Collaboration

Communication Skills

Formazione

Bachelor's degree in scientific or allied health field

Descrizione del lavoro

Vertex Pharmaceuticals LLC is seeking a GMP Operational Quality Senior Specialist Contractor to support quality assurance and regulatory compliance across Vertex and contracted suppliers. The role focuses on investigations, CAPA, change control, and timely batch release.

The candidate will lead quality metrics, root-cause analysis, and risk mitigation within a fast-paced pharmaceutical environment, reporting to the Senior Manager, GMP Operational Quality.