Veritas Search Group
Sr. Manager, Biomarker Operational Quality
Veritas Search Group, Boston, Massachusetts, us, 02298
Overview
Sr. Manager, Biomarker Operational Quality — Veritas Search Group This role supports leadership and oversight across GxP-regulated activities related to the research, development, and potential commercialization of clinical biomarkers, including their integration into clinical trials and transformation into in vitro diagnostics (IVDs). The position collaborates with Biomarker Operations and Quality teams to develop and monitor quality indicators and metrics, ensuring quality outcomes, operational excellence, inspection readiness, and vendor quality oversight. Base pay range : $85.00/hr - $93.00/hr This role is fully remote but requires EST hours to be worked. It requires candidates who are authorized to work in the U.S. without sponsorship; C2C arrangements are not accepted. Direct message the job poster from Veritas Search Group. This role is posted by Veritas Search Group. Application note:
Please submit your resume to recruiters@vsearchgroup.com if you are interested. Thank you! Responsibilities
Partner on quality oversight of preclinical and clinical activities (e.g., fit-for-purpose validations and associated processes) across therapeutic modalities. Contribute to regulatory document reviews (e.g., Briefing Books, INDs, IDEs, Trial Master Files), identifying potential compliance risks or gaps. Support the development of GCLP and GCP Biomarker vendor audit scopes and focus areas. Engage in business initiatives related to procedures, systems, and regulatory tools that support non-clinical and clinical activities. Participate in cross-functional initiatives to improve compliance with applicable regulations, standards, and internal policies. Identify potential compliance risks that could impact business objectives and implement pragmatic solutions. Support proactive reporting and communication of significant quality issues in biomarker-related development activities. Contribute to inspection readiness activities, including quality assessments of GLP/GCP biomarker studies. Advise on audit strategy for biomarker vendors, systems, and processes. Collaborate with R&D vendor quality groups to assess vendor performance and risk. Participate in governance forums to provide input on quality metrics and risk-based insights. Design and monitor quality metrics specific to biomarker-related activities in collaboration with clinical, preclinical, and quality stakeholders. Communicate trends and key insights related to preclinical and clinical study quality to relevant stakeholders. Participate in due diligence and integration activities when needed. Knowledge and Skills
Strong knowledge of applicable regulations and standards (e.g., CLIA 42 CFR Part 493, ISO15189:2022, CLSI). Proven ability to collaborate across departments and levels in a fast-paced, dynamic environment. Experience with quality metrics, dashboards, and continuous improvement initiatives. Excellent communication skills with a track record of promoting a culture of quality and compliance. Strong analytical and problem-solving skills to support sound decision-making. Minimum Qualifications
Bachelor\'s degree in a scientific or allied health discipline. Typically requires at least 6 years of relevant experience, or an equivalent combination of education and experience. Application Instructions
Please submit your resume and send to recruiters@vsearchgroup.com if you are interested. Thank you! Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Quality Assurance Industries: Hospitals and Health Care Referrals increase your chances of interviewing at Veritas Search Group by 2x
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Sr. Manager, Biomarker Operational Quality — Veritas Search Group This role supports leadership and oversight across GxP-regulated activities related to the research, development, and potential commercialization of clinical biomarkers, including their integration into clinical trials and transformation into in vitro diagnostics (IVDs). The position collaborates with Biomarker Operations and Quality teams to develop and monitor quality indicators and metrics, ensuring quality outcomes, operational excellence, inspection readiness, and vendor quality oversight. Base pay range : $85.00/hr - $93.00/hr This role is fully remote but requires EST hours to be worked. It requires candidates who are authorized to work in the U.S. without sponsorship; C2C arrangements are not accepted. Direct message the job poster from Veritas Search Group. This role is posted by Veritas Search Group. Application note:
Please submit your resume to recruiters@vsearchgroup.com if you are interested. Thank you! Responsibilities
Partner on quality oversight of preclinical and clinical activities (e.g., fit-for-purpose validations and associated processes) across therapeutic modalities. Contribute to regulatory document reviews (e.g., Briefing Books, INDs, IDEs, Trial Master Files), identifying potential compliance risks or gaps. Support the development of GCLP and GCP Biomarker vendor audit scopes and focus areas. Engage in business initiatives related to procedures, systems, and regulatory tools that support non-clinical and clinical activities. Participate in cross-functional initiatives to improve compliance with applicable regulations, standards, and internal policies. Identify potential compliance risks that could impact business objectives and implement pragmatic solutions. Support proactive reporting and communication of significant quality issues in biomarker-related development activities. Contribute to inspection readiness activities, including quality assessments of GLP/GCP biomarker studies. Advise on audit strategy for biomarker vendors, systems, and processes. Collaborate with R&D vendor quality groups to assess vendor performance and risk. Participate in governance forums to provide input on quality metrics and risk-based insights. Design and monitor quality metrics specific to biomarker-related activities in collaboration with clinical, preclinical, and quality stakeholders. Communicate trends and key insights related to preclinical and clinical study quality to relevant stakeholders. Participate in due diligence and integration activities when needed. Knowledge and Skills
Strong knowledge of applicable regulations and standards (e.g., CLIA 42 CFR Part 493, ISO15189:2022, CLSI). Proven ability to collaborate across departments and levels in a fast-paced, dynamic environment. Experience with quality metrics, dashboards, and continuous improvement initiatives. Excellent communication skills with a track record of promoting a culture of quality and compliance. Strong analytical and problem-solving skills to support sound decision-making. Minimum Qualifications
Bachelor\'s degree in a scientific or allied health discipline. Typically requires at least 6 years of relevant experience, or an equivalent combination of education and experience. Application Instructions
Please submit your resume and send to recruiters@vsearchgroup.com if you are interested. Thank you! Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Quality Assurance Industries: Hospitals and Health Care Referrals increase your chances of interviewing at Veritas Search Group by 2x
#J-18808-Ljbffr