Biomarker GxP Quality Director — Hybrid

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 157,000 - 235,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Hybrid/On-site options

Job summary

Vertex Pharmaceuticals in Boston is seeking an Associate Director of Biomarker Operational Quality to lead quality oversight across GxP activities in research, development, and clinical trials. You will collaborate with Biomarker Operations and Quality to drive compliance and readiness for future needs.

Responsibilities include supporting audit strategies, regulatory document reviews, and developing metrics to monitor process health.

Qualifications

• Bachelor’s degree in a scientific or allied health field.
• Typically 10 years of experience in QA for GxP environments.
• Strong knowledge of data integrity principles (ALCOA).
• Experience with GLP and GCP in biomarker programs.

Responsibilities

• Provide Biomarker quality leadership across GxP activities in R&D and trials.
• Review regulatory documents (BBs, INDs, IDEs, TMFs) for risks.
• Develop audit strategies for GLP/GCP Biomarker vendors.
• Collaborate to design quality metrics and dashboards.
• Ensure inspection readiness and timely quality communications.

Skills

GxP Compliance

Audits

Quality Metrics

Cross-functional

GLP/GCP

Regulatory Compliance

Education

Bachelor's degree in a scientific field

Job description

Vertex Pharmaceuticals in Boston is seeking an Associate Director of Biomarker Operational Quality to lead quality oversight across GxP activities in research, development, and clinical trials. You will collaborate with Biomarker Operations and Quality to drive compliance and readiness for future needs.

Responsibilities include supporting audit strategies, regulatory document reviews, and developing metrics to monitor process health.