Base: $163,850 - $212,438 depending on location; b...
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8+ years qa experience in clinical development
Expert knowledge of ich/gcp and rbqm principles
Experience with risk assessment and mitigation strategies
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Bristol Myers Squibb is seeking an Associate Director of Asset Quality to oversee quality management in clinical trials, particularly in hematology, oncology, and cell therapy. The role requires extensive experience in quality assurance and regulatory compliance, along with strong communication and project management skills.
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Job Summary
This role is responsible for developing the Quality Performance Narrative at the ASSET and Trial level to document end-to-end risk-based quality management.
The position requires providing quality and compliance consultation to clinical trials teams throughout the study lifecycle and establishing feedback loops for mitigation strategies.
Bristol Myers Squibb offers competitive benefits including health coverage, financial well-being programs, and flexible work-life balance options.
Matching Summary
Match Score: 75
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Bristol Myers Squibb is seeking an Associate Director of Asset Quality to oversee quality management in clinical trials, particularly in hematology, oncology, and cell therapy. The role requires extensive experience in quality assurance and regulatory compliance, along with strong communication and project management skills.
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Salary
Base: $163,850 - $212,438 depending on location; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Comprehensive health, wellness, and retirement plans included
Skills & Requirements
Must-have
8+ years QA experience in clinical development
Expert knowledge of ICH/GCP and RBQM principles
Experience with risk assessment and mitigation strategies
Knowledge of Hematology, Oncology, and Cell Therapy therapeutic areas
Proven ability to lead regulatory inspection preparation
Nice-to-have
Strong analytical and conceptual problem-solving skills
Excellent presentation skills for senior management
Ability to foster a culture of continuous improvement
Experience with Quality by Design (QbD) principles
Global perspective on business operations and strategy
Key Requirements
B.S. or M.S. in Chemistry, Biology, Health, or Quality related field
Minimum 8+ years of QA experience or relevant quality management background
Extensive experience in regulatory inspection preparation and management