Biomarker GxP Quality Operations Director

Vertex Inc.; Boston (MA); Hybrid; USD 157,000 - 235,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Commuting subsidy

401(k) plan

Paid time off

Job summary

Vertex is seeking an Associate Director of Biomarker Operational Quality to provide leadership across GLP/GCP programs, collaborating with Biomarker Operations and R&D to ensure quality and risk management in biomarker development for regulatory submissions and potential commercialization.

The role focuses on developing meaningful quality metrics, inspection readiness, and governance with diverse stakeholders, reporting to the Director of GCP Biomarker Operational Quality.

Qualifications

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

Responsibilities

• Lead Biomarker quality oversight across GLP/GCP programs and related activities.
• Collaborate with Biomarker Operations and R&D to monitor quality indicators and metrics.
• Support development of audit strategies for GLP/GCP Biomarker vendors and processes.
• Contribute to governance meetings with quality and business stakeholders.

Skills

Quality leadership

GxP knowledge

Regulatory interpretation

Cross-functional collaboration

Analytical thinking

Communication

Risk assessment

Education

Bachelor’s Degree in a scientific or allied health field

Job description

Vertex is seeking an Associate Director of Biomarker Operational Quality to provide leadership across GLP/GCP programs, collaborating with Biomarker Operations and R&D to ensure quality and risk management in biomarker development for regulatory submissions and potential commercialization.

The role focuses on developing meaningful quality metrics, inspection readiness, and governance with diverse stakeholders, reporting to the Director of GCP Biomarker Operational Quality.