Associate Director, Quality Risk management
Bristol Myers Squibb
15 days ago
Remote friendly (Devens, MA)
United States
Operations
Position Summary
The Associate Director, RBQM - Hematology, Oncology, Cell Therapy, Immunology, Cardiology and Neuroscience will develop the Quality Narrative at the study and/or ASSET and Therapeutic Area 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 adjust mitigation strategies when new/unanticipated issues arise after trial start.
Key Responsibilities
- Develop the Quality Narrative (or equivalent) at study/ASSET/TA level for end-to-end risk-based quality management of CtQ data/processes/vendors.
- Partner in upstream protocol authoring to embed Quality by Design and identify CtQ data/processes/vendors with adequate risk mitigation.
- During trial conduct, provide feedback on risks to CtQ factors and adjust mitigation strategies as new issues arise; partner with CAPA CoE/Serious Breach pillar and Clinical Quality Assurance.
- Conduct study-level spot checks; assist with defining Acceptable Ranges/QTL and KRIs for CtQ data.
- Support complex/critical quality issues and serious breaches (TA level as needed).
- Provide quality/compliance consultation to clinical trials teams throughout the lifecycle.
- Provide regulatory intelligence; establish partnerships with stakeholders.
- Support monitoring/evaluation of CtQ factors and adapt quality plans.
- Provide R&D Quality expertise, training, best practices, and lessons learned.
- Ensure rapid communication/escalation of quality issues (including significant deviations/misconduct) to the business and Health Authorities as needed.
- Ensure compliance with ICH (E8, E6, E9) and other relevant requirements; conduct external engagement as needed.
Other
- Drive quality through proactive support, mentoring/coaching.
- Provide guidance for global/cross-functional execution of regulations.
- Lead multidisciplinary/cross-functional teams and large-scale initiatives.
- Serve as a credible technical/functional expert; share knowledge across disciplines.
Qualifications & Experience
- B.S. and/or M.S. in Chemistry, Biology, Health, or Quality (or equivalent combination).
- 8+ years QA or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.
Required Competencies
- Applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes, and Quality Assurance.
- Strong Risk Based Quality Management and applied risk management (assessment/analysis/evaluation/reporting/communication/treatment/continuous risk management).
- Understanding of therapeutic areas: Hematology, Oncology, Cell Therapy, Immunology, Cardiology, Neuroscience.
- Experience preparing for/managing regulatory inspections and follow-up.
- Analytical capability using data to formulate data-driven business questions; strong problem-solving.
- Professional communication and presentation skills.
- Project management; ability to manage complex assignments and deliver timely deliverables.
- Consider global implications; adapt to changing conditions; foster continuous improvement culture.
The Associate Director, RBQM - Hematology, Oncology, Cell Therapy, Immunology, Cardiology and Neuroscience will develop the Quality Narrative at the study and/or ASSET and Therapeutic Area 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 adjust mitigation strategies when new/unanticipated issues arise after trial start.
Key Responsibilities
- Develop the Quality Narrative (or equivalent) at study/ASSET/TA level for end-to-end risk-based quality management of CtQ data/processes/vendors.
- Partner in upstream protocol authoring to embed Quality by Design and identify CtQ data/processes/vendors with adequate risk mitigation.
- During trial conduct, provide feedback on risks to CtQ factors and adjust mitigation strategies as new issues arise; partner with CAPA CoE/Serious Breach pillar and Clinical Quality Assurance.
- Conduct study-level spot checks; assist with defining Acceptable Ranges/QTL and KRIs for CtQ data.
- Support complex/critical quality issues and serious breaches (TA level as needed).
- Provide quality/compliance consultation to clinical trials teams throughout the lifecycle.
- Provide regulatory intelligence; establish partnerships with stakeholders.
- Support monitoring/evaluation of CtQ factors and adapt quality plans.
- Provide R&D Quality expertise, training, best practices, and lessons learned.
- Ensure rapid communication/escalation of quality issues (including significant deviations/misconduct) to the business and Health Authorities as needed.
- Ensure compliance with ICH (E8, E6, E9) and other relevant requirements; conduct external engagement as needed.
Other
- Drive quality through proactive support, mentoring/coaching.
- Provide guidance for global/cross-functional execution of regulations.
- Lead multidisciplinary/cross-functional teams and large-scale initiatives.
- Serve as a credible technical/functional expert; share knowledge across disciplines.
Qualifications & Experience
- B.S. and/or M.S. in Chemistry, Biology, Health, or Quality (or equivalent combination).
- 8+ years QA or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.
Required Competencies
- Applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes, and Quality Assurance.
- Strong Risk Based Quality Management and applied risk management (assessment/analysis/evaluation/reporting/communication/treatment/continuous risk management).
- Understanding of therapeutic areas: Hematology, Oncology, Cell Therapy, Immunology, Cardiology, Neuroscience.
- Experience preparing for/managing regulatory inspections and follow-up.
- Analytical capability using data to formulate data-driven business questions; strong problem-solving.
- Professional communication and presentation skills.
- Project management; ability to manage complex assignments and deliver timely deliverables.
- Consider global implications; adapt to changing conditions; foster continuous improvement culture.