Duration: 12 months to start

Job Description

• Biomarker Operational Quality Associate Director provides Biomarker quality leadership and oversight across GxPs-related to research and development, implementation into clinical trials and potential commercialization of clinical biomarkers into IVDs (In-vitro diagnostics)
• Biomarker Operational Quality Associate Director will also collaborate with the Biomarker Operations team to review and support the development of meaningful quality indicators and metrics to permit ongoing evaluation of process and quality system health and identification of risks.
• Reports to the Director, GCP Biomarker Operational Quality

• Partners with appropriate quality/compliance oversight of preclinical and clinical activities (fit-for-purpose validations and associated processes) across modalities in collaboration with Clinical Biomarkers and with other internal stakeholders in the business and Quality
• Contributes in Regulatory Document reviews, including BBs, INDs, IDEs, and TMFs, identifying any potential risks or gaps.
• Provides input in development of requested and for-cause GCLP and GCP Biomarker audit scope/focus for vendor audits.
• Participates in strategic cross-functional initiatives to improve compliance to regulatory requirements, standards and internal company policies.
• Identifies and anticipates potential compliance issues; contributes to proactive reporting of significant quality issues; contributes to proactive inspection readiness activities
• Serves in an advisory/consultative role in the development of audit strategy for GLP/GCP Biomarker vendors, processes and systems.

• Broad knowledge of CLIA regulations (42 CFR Part 493), and international equivalents, and other applicable guidance(s) ISO15189:2022, CLSI, etc.
• Quality metrics, dashboards, analysis and improvement programs
• Collaborative, good communicator, leadership skills
• Bachelor’s degree and 6 years of work experience (or Master’s degree and 3-4 years’ experience)