Associate Director, Biomarker Quality Ops (Hybrid)

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

Job summary

Vertex Pharmaceuticals LLC seeks an Associate Director, Biomarker Operational Quality to lead quality oversight across GxP activities from research through potential commercialization of biomarkers into IVDs. You will collaborate with business partners to drive compliance, readiness, and quality metrics across programs.

You will support audit strategies, contribute to regulatory document reviews, and partner with Clinical Biomarkers and Quality teams to ensure inspection readiness and robust

Qualifications

• Bachelor's Degree in a scientific or allied health field.
• Typically requires 6 years experience or the equivalent combination of education and experience.

Responsibilities

• Provide quality leadership for clinical biomarker activities across GMP/GCP.
• Review regulatory documents (BBs, INDs, IDEs, DHFs, TMFs) for risks or gaps.
• Contribute to GMP/GCP biomarker audit scope and vendor audits.
• Support processes, procedures, regulations and tools for non-clinical activities.
• Participate in cross-functional initiatives to improve regulatory compliance.
• Identify and address potential compliance issues to meet business goals.
• Report significant quality issues and support inspection readiness.
• Develop audit strategies for GMP/GCP biomarker vendors and systems.
• Engage with R&D vendor quality for vendor performance and risks.
• Contribute to governance meetings with metrics for stakeholders.
• Collaborate to design quality metrics for biomarker activities.
• May participate in due diligence and integration activities.

Skills

CLIA/IVDR knowledge

Cross-functional collaboration

Quality metrics

Communication skills

Problem solving

Education

Bachelor's degree in science/health

Job description

Vertex Pharmaceuticals LLC seeks an Associate Director, Biomarker Operational Quality to lead quality oversight across GxP activities from research through potential commercialization of biomarkers into IVDs. You will collaborate with business partners to drive compliance, readiness, and quality metrics across programs.

You will support audit strategies, contribute to regulatory document reviews, and partner with Clinical Biomarkers and Quality teams to ensure inspection readiness and robust