Associate Director, Quality Risk Specialist
Scorpion Therapeutics, Madison, New Jersey, us, 07940
Role Summary
The Associate Director, RBQM - HOCT, ICN will develop the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality (CtQ) 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 the 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 and identify CtQ data, processes and vendors, ensuring adequate risk mitigation strategies are implemented. During trial conduct, provide feedback on risks to CtQ factors and adjust mitigation strategies as new issues arise, collaborating with CAPA CoE, Serious Breach pillar, and Clinical Quality Assurance to inform QbD. Conduct quality assurance spot checks at the study level to ensure risk mitigation strategies are translated into operational plans. Assist 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 to ensure compliance with applicable requirements. Establish strong partnerships with business stakeholders. Collaborate with 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, critical thinking, training, and share best practices for future trials. Ensure rapid communication and escalation of quality issues to the business and Health Authorities as needed. Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements. Engage externally with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as needed. Education
B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience Qualifications
Minimum 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance. Skills
Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance Very experienced in Risk Based Quality Management principles In-depth knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and continuous risk management Understanding of BMS's therapeutic areas - HOCT and ICN Extensive experience in regulatory inspection preparation, management, and follow-up Analytical and conceptual capability, including proficiency in using data to answer clear business questions Strong problem-solving skills to prevent and overcome complex quality issues during clinical program implementation Professional communication skills, with clear written and verbal communication and strong presentation abilities Project management skills to manage complex assignments and deliver deliverables on time Global mindset with ability to anticipate and adapt to global influences and regulatory environments Commitment to continuous improvement and knowledge sharing across teams Additional Requirements
Hybrid work eligibility as applicable
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The Associate Director, RBQM - HOCT, ICN will develop the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality (CtQ) 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 the 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 and identify CtQ data, processes and vendors, ensuring adequate risk mitigation strategies are implemented. During trial conduct, provide feedback on risks to CtQ factors and adjust mitigation strategies as new issues arise, collaborating with CAPA CoE, Serious Breach pillar, and Clinical Quality Assurance to inform QbD. Conduct quality assurance spot checks at the study level to ensure risk mitigation strategies are translated into operational plans. Assist 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 to ensure compliance with applicable requirements. Establish strong partnerships with business stakeholders. Collaborate with 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, critical thinking, training, and share best practices for future trials. Ensure rapid communication and escalation of quality issues to the business and Health Authorities as needed. Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements. Engage externally with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as needed. Education
B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience Qualifications
Minimum 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance. Skills
Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance Very experienced in Risk Based Quality Management principles In-depth knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and continuous risk management Understanding of BMS's therapeutic areas - HOCT and ICN Extensive experience in regulatory inspection preparation, management, and follow-up Analytical and conceptual capability, including proficiency in using data to answer clear business questions Strong problem-solving skills to prevent and overcome complex quality issues during clinical program implementation Professional communication skills, with clear written and verbal communication and strong presentation abilities Project management skills to manage complex assignments and deliver deliverables on time Global mindset with ability to anticipate and adapt to global influences and regulatory environments Commitment to continuous improvement and knowledge sharing across teams Additional Requirements
Hybrid work eligibility as applicable
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