Biomarker GxP Quality Director

MFS Investments; Boston (MA); Hybrid; USD 157,000 - 235,000; Full time

Job summary

Vertex is a global biotechnology company seeking a Biomarker Operational Quality Associate Director to provide quality leadership across GxP activities from research through potential commercialization of biomarkers. You will collaborate with Clinical Biomarkers and Quality to drive compliance, excellence, and readiness for future needs.

In this hybrid-eligible role, you will help design quality metrics, influence governance discussions, and support regulatory document reviews while aligning

Qualifications

• Bachelor’s Degree in a scientific or allied health field.
• Typically requires 10 years’ experience or the equivalent combination of education and experience.
• Strong knowledge of data integrity principles and ALCOA.

Responsibilities

• Provide quality leadership across GxP activities from research to potential commercialization of biomarkers.
• Collaborate with Clinical Biomarkers and quality to drive compliance and operational excellence.
• Support regulatory document reviews (BBs, INDs, IDEs, TMFs) and risk identification.
• Develop audit scopes and participate in vendor audits for GLP/GCP Biomarker work.
• Design quality metrics and dashboards to monitor process health and risks.
• Support inspection readiness and governance meetings with stakeholders.
• Train Research staff on Vertex policies and non-GxP QA processes.

Skills

GxP compliance

Data integrity (ALCOA)

Quality metrics

Cross-functional collaboration

Regulatory document reviews

Analytical thinking

Communication skills

Education

Bachelor’s Degree in a scientific or allied health field

Job description

Vertex is a global biotechnology company seeking a Biomarker Operational Quality Associate Director to provide quality leadership across GxP activities from research through potential commercialization of biomarkers. You will collaborate with Clinical Biomarkers and Quality to drive compliance, excellence, and readiness for future needs.

In this hybrid-eligible role, you will help design quality metrics, influence governance discussions, and support regulatory document reviews while aligning