Clear Point Consultants
Senior Manager of Biomarker Operational Quality
Clear Point Consultants, Boston, Massachusetts, us, 02298
Overview
As the Senior Manager of Biomarker Operational Quality, you’ll be the go-to person for making sure biomarker-related work across research, clinical trials, and potential commercial use stays aligned with regulatory standards (GxP). You’ll work closely with internal teams—especially Biomarker Ops and GCP Quality—to help drive operational excellence, keep things compliant, and spot potential risks before they become issues. Your job is to help ensure the processes around biomarker development—including those supporting Companion Diagnostics (CDx)—are efficient, compliant, and future-ready. You’ll also help define and track quality metrics that give a clear picture of how well things are working and where improvements can be made. You’ll report to the Director of GCP Biomarker Quality and team up with others in Quality to keep processes consistent across programs and products. Responsibilities
Partnering with clinical and preclinical teams to support biomarker quality throughout development Helping review regulatory documents (like INDs, IDEs, and trial master files) and calling out potential gaps Providing input for audits focused on GCLP and GCP biomarker-related vendors and activities Supporting process and compliance improvements across non-clinical areas Joining cross-functional initiatives to strengthen how the organization meets regulatory standards Flagging potential compliance issues and helping design smart, realistic solutions Reporting on major quality concerns tied to preclinical development Leading or supporting inspection readiness activities for biomarker-related work Advising on audit strategies for vendors and internal processes Helping assess vendor performance and quality risk Attending key governance meetings and contributing to agendas and metrics Collaborating with stakeholders to define and refine quality indicators for biomarker efforts Sharing quality trends and insights with the right people at the right time Providing quality and compliance oversight for CDx development and validation activities, including alignment with regulatory requirements for diagnostic-device submissions and commercialization Partnering with internal and external stakeholders to ensure CDx-related processes are inspection-ready and meet FDA, EU IVDR, and other global expectations Possibly contributing to due diligence and integration projects Qualifications
Solid knowledge of lab regulations like CLIA, ISO15189:2022, CLSI, and others Familiarity with CDx lifecycle and regulatory pathways for diagnostic products Experience navigating fast-paced environments and working across teams Familiarity with quality metrics, dashboards, and continuous improvement Strong communication skills—you know how to make quality make sense Problem-solving skills to help resolve issues thoughtfully and quickly Job Details
Employment type: Contract Job function: Quality Assurance and Project Management Industries: Pharmaceutical Manufacturing
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As the Senior Manager of Biomarker Operational Quality, you’ll be the go-to person for making sure biomarker-related work across research, clinical trials, and potential commercial use stays aligned with regulatory standards (GxP). You’ll work closely with internal teams—especially Biomarker Ops and GCP Quality—to help drive operational excellence, keep things compliant, and spot potential risks before they become issues. Your job is to help ensure the processes around biomarker development—including those supporting Companion Diagnostics (CDx)—are efficient, compliant, and future-ready. You’ll also help define and track quality metrics that give a clear picture of how well things are working and where improvements can be made. You’ll report to the Director of GCP Biomarker Quality and team up with others in Quality to keep processes consistent across programs and products. Responsibilities
Partnering with clinical and preclinical teams to support biomarker quality throughout development Helping review regulatory documents (like INDs, IDEs, and trial master files) and calling out potential gaps Providing input for audits focused on GCLP and GCP biomarker-related vendors and activities Supporting process and compliance improvements across non-clinical areas Joining cross-functional initiatives to strengthen how the organization meets regulatory standards Flagging potential compliance issues and helping design smart, realistic solutions Reporting on major quality concerns tied to preclinical development Leading or supporting inspection readiness activities for biomarker-related work Advising on audit strategies for vendors and internal processes Helping assess vendor performance and quality risk Attending key governance meetings and contributing to agendas and metrics Collaborating with stakeholders to define and refine quality indicators for biomarker efforts Sharing quality trends and insights with the right people at the right time Providing quality and compliance oversight for CDx development and validation activities, including alignment with regulatory requirements for diagnostic-device submissions and commercialization Partnering with internal and external stakeholders to ensure CDx-related processes are inspection-ready and meet FDA, EU IVDR, and other global expectations Possibly contributing to due diligence and integration projects Qualifications
Solid knowledge of lab regulations like CLIA, ISO15189:2022, CLSI, and others Familiarity with CDx lifecycle and regulatory pathways for diagnostic products Experience navigating fast-paced environments and working across teams Familiarity with quality metrics, dashboards, and continuous improvement Strong communication skills—you know how to make quality make sense Problem-solving skills to help resolve issues thoughtfully and quickly Job Details
Employment type: Contract Job function: Quality Assurance and Project Management Industries: Pharmaceutical Manufacturing
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