Biomarker Quality & Compliance Director

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 124,000 - 134,000; Full time

Job summary

Vertex Pharmaceuticals seeks a Biomarker Operational Quality Associate Director to provide leadership across GxP activities tied to biomarker development, clinical trials, and potential IVDs. You will collaborate with Clinical Biomarkers and Quality teams to ensure regulatory readiness and value-driven quality oversight.

Responsibilities include driving GxP quality across programs, developing meaningful quality metrics, and supporting inspection readiness while partnering with R&D and vendor

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Typically requires 6 years experience or equivalent combination of education and experience.
• Strong knowledge of CLIA regulations (42 CFR Part 493), IVDR and international equivalents (ISO15189:2022, CLSI).
• Excellent communication and collaboration skills; ability to influence and promote quality culture.

Responsibilities

• Provide quality oversight for clinical (GMP/GCP) biomarker activities and medical device interfaces.
• Support Regulatory Document reviews (BBs, INDs, IDEs, DHFs, TMFs) and risk identification.
• Contribute to GMP/GCP biomarker audit scope and vendor audits.
• Develop and implement quality improvement methods across processes and tools.
• Participate in governance meetings and provide meaningful quality metrics.

Skills

GxP knowledge

Cross-functional collaboration

Quality metrics

Communication skills

Problem solving

Education

Bachelor's Degree in a scientific or allied health field

Job description

Vertex Pharmaceuticals seeks a Biomarker Operational Quality Associate Director to provide leadership across GxP activities tied to biomarker development, clinical trials, and potential IVDs. You will collaborate with Clinical Biomarkers and Quality teams to ensure regulatory readiness and value-driven quality oversight.

Responsibilities include driving GxP quality across programs, developing meaningful quality metrics, and supporting inspection readiness while partnering with R&D and vendor