Veritas Search Group
Associate Director, Biomarker Operational Quality
Veritas Search Group, Boston, Massachusetts, us, 02298
Associate Director, Biomarker Operational Quality Join to apply for the
Associate Director, Biomarker Operational Quality
role at
Veritas Search Group
Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience. Associate Director, Biomarker Operational Quality 3 days ago Be among the first 25 applicants Join to apply for the
Associate Director, Biomarker Operational Quality
role at
Veritas Search Group This range is provided by Veritas Search Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $85.00/hr - $93.00/hr Direct message the job poster from Veritas Search Group This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted. This role is fully remote but requires EST hours to be worked. General Position Summary: The
Associate Director, Biomarker Operational Quality , provides 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). This individual works closely with internal stakeholders to ensure quality outcomes and operational excellence, driving proactive oversight and supporting continuous improvement initiatives. This role collaborates with Biomarker Operations and Quality teams to develop and monitor quality indicators and metrics that assess process performance, quality system health, and emerging risks. The position also contributes to inspection readiness, audit strategy, and vendor quality oversight to support high standards of compliance and effectiveness. Key Responsibilities: Responsibilities may include, but are not limited to: Partnering on quality oversight of preclinical and clinical activities (e.g., fit-for-purpose validations and associated processes) across therapeutic modalities. Contributing to regulatory document reviews (e.g., Briefing Books, INDs, IDEs, Trial Master Files), identifying potential compliance risks or gaps. Supporting the development of GCLP and GCP Biomarker vendor audit scopes and focus areas. Engaging in business initiatives related to procedures, systems, and regulatory tools that support non-clinical and clinical activities. Participating in cross-functional initiatives to improve compliance with applicable regulations, standards, and internal policies. Identifying potential compliance risks that could impact business objectives and implementing pragmatic solutions. Supporting proactive reporting and communication of significant quality issues in biomarker-related development activities. Contributing to inspection readiness activities, including quality assessments of GLP/GCP biomarker studies. Advising on audit strategy for biomarker vendors, systems, and processes. Collaborating with R&D vendor quality groups to assess vendor performance and risk. Participating in governance forums to provide input on quality metrics and risk-based insights. Designing and monitoring quality metrics specific to biomarker-related activities in collaboration with clinical, preclinical, and quality stakeholders. Communicating trends and key insights related to preclinical and clinical study quality to relevant stakeholders. Participating 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. Please submit your resume and send to recruiters@vsearchgroup.com if you are interested. Thank you! Seniority level
Seniority levelMid-Senior level Employment type
Employment typeContract Job function
Job functionQuality Assurance IndustriesHospitals and Health Care Referrals increase your chances of interviewing at Veritas Search Group by 2x Get notified about new Director of Quality jobs in
Boston, MA . Sr. Director, R&D Quality and ComplianceSenior Director, Operational Quality & ComplianceSr. Director, R&D Quality and Compliance Waltham, MA $186,000.00-$255,000.00 2 days ago Director, Global GxP Regulatory Intelligence (Remote)Senior Medical Director, Pharmacovigilance and Safety Waltham, MA $265,000.00-$295,000.00 2 months ago Director Clinical Documentation IntegrityAssociate Director, Regulatory Affairs Strategy Cambridge, MA $149,069.00-$223,604.00 1 month ago Waltham, MA $205,000.00-$260,000.00 4 months ago Cambridge, MA $143,250.00-$210,100.00 1 week ago Public Relations Account Director (B2B Technology, Cybersecurity, Financial Services)Sr. Medical Director, Gastrointestinal and Inflammation (Remote) Boston, MA $257,600.00-$404,800.00 23 hours ago Boston, MA $174,500.00-$274,230.00 2 weeks ago Sr. Manager, Clinical Document Specialist (Remote) Bedford, MA $128,000.00-$192,000.00 1 week ago Senior Manager/Associate Director - CMC Analytical Development (Fully Remote), Pulmovant Waltham, MA $194,000.00-$213,000.00 2 months ago MassHealth Regulatory Compliance & Audits SpecialistClinical Scientist, Clinical Development Waltham, MA $140,000.00-$155,000.00 2 months ago Manager of Learning and Development- Contact CenterMedical Project Management, Medical & Scientific CommunicationDirector of Advanced Practice - FNP Program We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Associate Director, Biomarker Operational Quality
role at
Veritas Search Group
Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience. Associate Director, Biomarker Operational Quality 3 days ago Be among the first 25 applicants Join to apply for the
Associate Director, Biomarker Operational Quality
role at
Veritas Search Group This range is provided by Veritas Search Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $85.00/hr - $93.00/hr Direct message the job poster from Veritas Search Group This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted. This role is fully remote but requires EST hours to be worked. General Position Summary: The
Associate Director, Biomarker Operational Quality , provides 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). This individual works closely with internal stakeholders to ensure quality outcomes and operational excellence, driving proactive oversight and supporting continuous improvement initiatives. This role collaborates with Biomarker Operations and Quality teams to develop and monitor quality indicators and metrics that assess process performance, quality system health, and emerging risks. The position also contributes to inspection readiness, audit strategy, and vendor quality oversight to support high standards of compliance and effectiveness. Key Responsibilities: Responsibilities may include, but are not limited to: Partnering on quality oversight of preclinical and clinical activities (e.g., fit-for-purpose validations and associated processes) across therapeutic modalities. Contributing to regulatory document reviews (e.g., Briefing Books, INDs, IDEs, Trial Master Files), identifying potential compliance risks or gaps. Supporting the development of GCLP and GCP Biomarker vendor audit scopes and focus areas. Engaging in business initiatives related to procedures, systems, and regulatory tools that support non-clinical and clinical activities. Participating in cross-functional initiatives to improve compliance with applicable regulations, standards, and internal policies. Identifying potential compliance risks that could impact business objectives and implementing pragmatic solutions. Supporting proactive reporting and communication of significant quality issues in biomarker-related development activities. Contributing to inspection readiness activities, including quality assessments of GLP/GCP biomarker studies. Advising on audit strategy for biomarker vendors, systems, and processes. Collaborating with R&D vendor quality groups to assess vendor performance and risk. Participating in governance forums to provide input on quality metrics and risk-based insights. Designing and monitoring quality metrics specific to biomarker-related activities in collaboration with clinical, preclinical, and quality stakeholders. Communicating trends and key insights related to preclinical and clinical study quality to relevant stakeholders. Participating 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. Please submit your resume and send to recruiters@vsearchgroup.com if you are interested. Thank you! Seniority level
Seniority levelMid-Senior level Employment type
Employment typeContract Job function
Job functionQuality Assurance IndustriesHospitals and Health Care Referrals increase your chances of interviewing at Veritas Search Group by 2x Get notified about new Director of Quality jobs in
Boston, MA . Sr. Director, R&D Quality and ComplianceSenior Director, Operational Quality & ComplianceSr. Director, R&D Quality and Compliance Waltham, MA $186,000.00-$255,000.00 2 days ago Director, Global GxP Regulatory Intelligence (Remote)Senior Medical Director, Pharmacovigilance and Safety Waltham, MA $265,000.00-$295,000.00 2 months ago Director Clinical Documentation IntegrityAssociate Director, Regulatory Affairs Strategy Cambridge, MA $149,069.00-$223,604.00 1 month ago Waltham, MA $205,000.00-$260,000.00 4 months ago Cambridge, MA $143,250.00-$210,100.00 1 week ago Public Relations Account Director (B2B Technology, Cybersecurity, Financial Services)Sr. Medical Director, Gastrointestinal and Inflammation (Remote) Boston, MA $257,600.00-$404,800.00 23 hours ago Boston, MA $174,500.00-$274,230.00 2 weeks ago Sr. Manager, Clinical Document Specialist (Remote) Bedford, MA $128,000.00-$192,000.00 1 week ago Senior Manager/Associate Director - CMC Analytical Development (Fully Remote), Pulmovant Waltham, MA $194,000.00-$213,000.00 2 months ago MassHealth Regulatory Compliance & Audits SpecialistClinical Scientist, Clinical Development Waltham, MA $140,000.00-$155,000.00 2 months ago Manager of Learning and Development- Contact CenterMedical Project Management, Medical & Scientific CommunicationDirector of Advanced Practice - FNP Program We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr