Bristol Myers Squibb
Associate Director, Quality Risk Specialist
Bristol Myers Squibb, New Brunswick, New Jersey, us, 08933
Associate Director, Quality Risk Specialist
The Associate Director, RBQM - HOCT, ICN will be responsible for developing the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality data, processes, and vendors, demonstrating effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout the study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun. Responsibilities
Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level to document end-to-end risk-based quality management for CtQ data, processes and vendors, demonstrating effective risk and issue management. Partner with Drug Development to embed Quality by Design principles during upstream protocol authoring and identify study-specific CtQ data, processes and vendors, ensuring adequate risk mitigation strategies are implemented. During trial conduct, provide feedback on risks to CtQ factors and ensure mitigation strategies are adjusted as new or unanticipated issues arise; collaborate with CAPA CoE, Serious Breach pillar, and Clinical Quality Assurance to inform QbD from audits, inspections, internal quality events, significant issues, and external intelligence. Conduct quality assurance spot checks at the study level to ensure risk mitigation strategies are translated into operational plans. Assist the business in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data. Support for cause, critical and/or complex quality issues and serious breaches for the TA as needed. Provide regulatory intelligence on current and upcoming regulations to ensure compliance with applicable requirements. Establish strong partnerships with business stakeholders and study teams to manage significant quality issues/noncompliance and important protocol deviations for CtQ data, processes and vendors. Monitor and evaluate CtQ factors throughout the study lifecycle and adapt Quality plans accordingly. Provide R&D Quality expertise, deliver training, and share best practices and lessons learned to future trials. Ensure rapid communication and escalation of quality issues, including potential misconduct or significant deviations with project/products to the business and Health Authorities, as needed. Ensure compliance with ICH standards (E8, E6, E9) and other regulatory requirements; engage with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as appropriate. Qualifications & Experience
B.S. and/or M.S. in Chemistry, Biology, Health or Quality-related field or equivalent combination of education, training, and experience Minimum 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance Required Competencies
Demonstrated knowledge of ICH/GCP, regulatory guidelines, clinical research processes and Quality Assurance principles Experience in Risk Based Quality Management Applied risk-management knowledge including risk assessment, analysis, evaluation, reporting and communication, risk treatment and continuous risk management Understanding of BMS therapeutic areas HOCT and ICN Experience in regulatory inspection preparation, management, and follow-up Analytical and conceptual capability with data-driven problem solving Strong communication skills, professional writing, and presentation abilities Project management skills to manage complex assignments and deliver results on time Ability to consider global influences and adapt plans accordingly Proactive in improving services and processes Other Information
Hybrid work options may be available depending on role requirements Equal Employment Opportunity statement and accommodations: BMS provides reasonable accommodations during the recruitment process and on an ongoing basis; inquiries can be directed to adastaffingsupport@bms.com Location and compensation details are provided in the job posting. Data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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The Associate Director, RBQM - HOCT, ICN will be responsible for developing the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality data, processes, and vendors, demonstrating effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout the study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun. Responsibilities
Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level to document end-to-end risk-based quality management for CtQ data, processes and vendors, demonstrating effective risk and issue management. Partner with Drug Development to embed Quality by Design principles during upstream protocol authoring and identify study-specific CtQ data, processes and vendors, ensuring adequate risk mitigation strategies are implemented. During trial conduct, provide feedback on risks to CtQ factors and ensure mitigation strategies are adjusted as new or unanticipated issues arise; collaborate with CAPA CoE, Serious Breach pillar, and Clinical Quality Assurance to inform QbD from audits, inspections, internal quality events, significant issues, and external intelligence. Conduct quality assurance spot checks at the study level to ensure risk mitigation strategies are translated into operational plans. Assist the business in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data. Support for cause, critical and/or complex quality issues and serious breaches for the TA as needed. Provide regulatory intelligence on current and upcoming regulations to ensure compliance with applicable requirements. Establish strong partnerships with business stakeholders and study teams to manage significant quality issues/noncompliance and important protocol deviations for CtQ data, processes and vendors. Monitor and evaluate CtQ factors throughout the study lifecycle and adapt Quality plans accordingly. Provide R&D Quality expertise, deliver training, and share best practices and lessons learned to future trials. Ensure rapid communication and escalation of quality issues, including potential misconduct or significant deviations with project/products to the business and Health Authorities, as needed. Ensure compliance with ICH standards (E8, E6, E9) and other regulatory requirements; engage with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as appropriate. Qualifications & Experience
B.S. and/or M.S. in Chemistry, Biology, Health or Quality-related field or equivalent combination of education, training, and experience Minimum 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance Required Competencies
Demonstrated knowledge of ICH/GCP, regulatory guidelines, clinical research processes and Quality Assurance principles Experience in Risk Based Quality Management Applied risk-management knowledge including risk assessment, analysis, evaluation, reporting and communication, risk treatment and continuous risk management Understanding of BMS therapeutic areas HOCT and ICN Experience in regulatory inspection preparation, management, and follow-up Analytical and conceptual capability with data-driven problem solving Strong communication skills, professional writing, and presentation abilities Project management skills to manage complex assignments and deliver results on time Ability to consider global influences and adapt plans accordingly Proactive in improving services and processes Other Information
Hybrid work options may be available depending on role requirements Equal Employment Opportunity statement and accommodations: BMS provides reasonable accommodations during the recruitment process and on an ongoing basis; inquiries can be directed to adastaffingsupport@bms.com Location and compensation details are provided in the job posting. Data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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