Associate Director, GCP Operational Quality - Biomarkers

Vertex Pharmaceuticals

Vertex Pharmaceuticals seeks an Associate Director to lead biomarker operational quality across research and development, clinical trials, and commercialization. The role oversees GxP compliance, quality metrics, and regulatory readiness while collaborating with cross-functional teams to ensure excellence and operational delivery.

Responsibilities

Oversee quality and compliance of preclinical and clinical biomarker activities across modalities
Review regulatory documents including INDs, IDEs, and regulatory submissions for risks and gaps
Develop and support audit strategy for GLP/GCP biomarker vendors and processes
Conduct Research QA reviews of non-GxP protocols and reports for regulatory submissions
Design quality metrics and communicate trending insights to business and quality stakeholders

Requirements

Bachelor's degree in scientific or allied health field
10+ years experience in quality, biomarker development, or related field
Deep knowledge of CLIA regulations and international equivalents
Strong GxP compliance experience including GLP and medical device requirements
Demonstrated expertise in data integrity principles and ALCOA
Ability to develop and interpret quality metrics and dashboards
Excellent cross-functional collaboration and communication skills

Apply

Vacancy posted 2 days ago

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