Associate Director, Asset Quality
Bristol Myers Squibb
3 months ago
Remote friendly (Princeton, NJ)
United States
Operations
Position Summary
- Develop the Quality Performance Narrative to document end-to-end RBQM for CtQ data, processes, and vendors, demonstrating effective risk and issue management.
- Provide quality/compliance consultation to clinical trials teams across the study lifecycle and ensure mitigation strategies are updated when new issues arise.
Qualifications & Experience
- B.S. and/or M.S. in Chemistry, Biology, or Health/Quality related field (or equivalent).
- 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.
Required Competencies / Skills
- Applied knowledge of ICH/GCP, regulatory guidelines, clinical research processes, and Quality Assurance.
- Very experienced in Risk Based Quality Management.
- In-depth risk management (assessment, analysis, evaluation, reporting/communication, treatment, and continuous review).
- Knowledge of therapeutic areas: Hematology, Oncology, Cell Therapy, Immunology, Cardiovascular, Neuroscience.
- Extensive regulatory inspection preparation/management and follow-up.
- Strong analytical skills using data to answer business questions.
- Project management, communication, problem-solving, and ability to work with global influences.
Key Responsibilities
- Embed Quality by Design in protocol authoring; identify CtQ data/processes/vendors and ensure risk mitigations.
- During trial conduct: provide risk feedback and adjust mitigations with input from audits/inspections/internal events, CAPA, and serious breach processes.
- Perform study-level spot checks; define Acceptable Ranges/QTL and KRIs; support complex quality issues/CtQ serious breaches.
- Provide regulatory intelligence, SOP feedback, training, best practices, escalation of quality issues, and ensure compliance with ICH (E8, E6, E9).
- Lead/participate in cross-functional initiatives and external engagement as needed.
Benefits (explicitly listed)
- Health coverage (medical/pharmacy/dental/vision), wellbeing support (EAP, wellbeing programs), financial wellbeing/protection (401(k), life/disability/insurance, etc.), and paid time off.
Application instruction
- If interested but not a perfect resume match, apply anyway.
- Develop the Quality Performance Narrative to document end-to-end RBQM for CtQ data, processes, and vendors, demonstrating effective risk and issue management.
- Provide quality/compliance consultation to clinical trials teams across the study lifecycle and ensure mitigation strategies are updated when new issues arise.
Qualifications & Experience
- B.S. and/or M.S. in Chemistry, Biology, or Health/Quality related field (or equivalent).
- 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.
Required Competencies / Skills
- Applied knowledge of ICH/GCP, regulatory guidelines, clinical research processes, and Quality Assurance.
- Very experienced in Risk Based Quality Management.
- In-depth risk management (assessment, analysis, evaluation, reporting/communication, treatment, and continuous review).
- Knowledge of therapeutic areas: Hematology, Oncology, Cell Therapy, Immunology, Cardiovascular, Neuroscience.
- Extensive regulatory inspection preparation/management and follow-up.
- Strong analytical skills using data to answer business questions.
- Project management, communication, problem-solving, and ability to work with global influences.
Key Responsibilities
- Embed Quality by Design in protocol authoring; identify CtQ data/processes/vendors and ensure risk mitigations.
- During trial conduct: provide risk feedback and adjust mitigations with input from audits/inspections/internal events, CAPA, and serious breach processes.
- Perform study-level spot checks; define Acceptable Ranges/QTL and KRIs; support complex quality issues/CtQ serious breaches.
- Provide regulatory intelligence, SOP feedback, training, best practices, escalation of quality issues, and ensure compliance with ICH (E8, E6, E9).
- Lead/participate in cross-functional initiatives and external engagement as needed.
Benefits (explicitly listed)
- Health coverage (medical/pharmacy/dental/vision), wellbeing support (EAP, wellbeing programs), financial wellbeing/protection (401(k), life/disability/insurance, etc.), and paid time off.
Application instruction
- If interested but not a perfect resume match, apply anyway.