Associate Director, Quality Risk Specialist
Bristol Myers Squibb
4 months ago
Remote friendly (Madison, NJ)
United States
Operations
Responsibilities:
- Develop the Quality Narrative (or equivalent) at study and/or ASSET and TA level to document end-to-end risk-based quality management for critical-to-quality (CtQ) data, processes, and vendors.
- Embed Quality by Design in upstream protocol authoring; identify CtQ data/processes/vendors and ensure risk mitigation strategies are implemented.
- During trial conduct, provide input on CtQ risks and adjust mitigation strategies when new/unanticipated issues arise; partner with CAPA CoE, Serious Breach pillar, and Clinical Quality Assurance to inform QbD.
- Conduct study-level quality assurance spot checks; assist with defining Acceptable Ranges/QTL and KRIs for CtQ data.
- Support cause/complex quality issues and serious breaches for the TA; provide quality/compliance consultation across the study lifecycle.
- Provide regulatory intelligence; manage significant quality issues/noncompliance and important protocol deviations.
- Adapt quality plans based on monitoring/evaluation of CtQ factors; provide training, share best practices/lessons learned.
- Ensure rapid escalation of quality issues (including potential misconduct/significant deviations), ensure ICH (E8, E6, E9) compliance, and engage externally as needed.
Qualifications:
- B.S. and/or M.S. in Chemistry, Biology, Health or Quality (or equivalent).
- 8+ years QA or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.
Required competencies/skills:
- Applied ICH/GCP, regulatory guidelines, clinical research quality assurance principles; strong risk-based quality management and risk-management lifecycle.
- Understanding of HOCT and ICN therapeutic areas; extensive regulatory inspection experience.
- Strong analytics/data use, problem-solving, communication, and project management; global mindset; mentorship/continuous improvement culture.
- Develop the Quality Narrative (or equivalent) at study and/or ASSET and TA level to document end-to-end risk-based quality management for critical-to-quality (CtQ) data, processes, and vendors.
- Embed Quality by Design in upstream protocol authoring; identify CtQ data/processes/vendors and ensure risk mitigation strategies are implemented.
- During trial conduct, provide input on CtQ risks and adjust mitigation strategies when new/unanticipated issues arise; partner with CAPA CoE, Serious Breach pillar, and Clinical Quality Assurance to inform QbD.
- Conduct study-level quality assurance spot checks; assist with defining Acceptable Ranges/QTL and KRIs for CtQ data.
- Support cause/complex quality issues and serious breaches for the TA; provide quality/compliance consultation across the study lifecycle.
- Provide regulatory intelligence; manage significant quality issues/noncompliance and important protocol deviations.
- Adapt quality plans based on monitoring/evaluation of CtQ factors; provide training, share best practices/lessons learned.
- Ensure rapid escalation of quality issues (including potential misconduct/significant deviations), ensure ICH (E8, E6, E9) compliance, and engage externally as needed.
Qualifications:
- B.S. and/or M.S. in Chemistry, Biology, Health or Quality (or equivalent).
- 8+ years QA or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.
Required competencies/skills:
- Applied ICH/GCP, regulatory guidelines, clinical research quality assurance principles; strong risk-based quality management and risk-management lifecycle.
- Understanding of HOCT and ICN therapeutic areas; extensive regulatory inspection experience.
- Strong analytics/data use, problem-solving, communication, and project management; global mindset; mentorship/continuous improvement culture.