Biomarker Quality Director, GxP/GCP Lead (Hybrid)

Vertex Pharmaceuticals Inc (US)

Boston (MA)

Hybrid

USD 157,000 - 235,000

Full time

9 days ago

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Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Paid time off

Tuition assistance

Commuting subsidy

401(k)

Job summary

Vertex Pharmaceuticals Incorporated seeks an Associate Director, Biomarkers Operational Quality to provide leadership and oversight across GxP activities from research through development, including potential commercialization of clinical biomarkers. You will drive quality outcomes, collaborate with Biomarker Operations and Quality partners, and use meaningful metrics to monitor process health and risk.

The role integrates with R&D, regulatory reviews, and vendor quality management to ensure

Qualifications

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

Responsibilities

Partner with quality/compliance oversight of preclinical and clinical activities across modalities in collaboration with Clinical Biomarkers and Quality.
Contributes to regulatory document reviews, including BBs, INDs, IDEs, and TMFs, identifying potential risks or gaps.
Provides input in development of GCLP and GCP Biomarker audit scope/focus for vendor audits.
Supports processes, procedures, regulations and tools to support non-clinical activities.
Designs quality metrics and participates in governance meetings to improve regulatory compliance across programs.