Associate Director, Asset Quality

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

The Associate Director, Asset Quality Lead – Hematology, Oncology, Cell Therapy, ICV and Neuroscience will mainly be responsible for developing the Quality Performance Narrative at the ASSET & Trial level 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 study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun.

Qualifications & Experience
Education and Experience:

• B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience

• Minimum 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.

Required Competencies:  Knowledge, Skills, and Abilities

• 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 the review of continuous risk management

• Understanding of BMS’s therapeutic areas – Hematology, Oncology, Cell Therapy, Immunology, Cardiovascular and Neuroscience.

• Extensive experience in regulatory inspection preparation, management, and related follow-up.

• Demonstrated analytical and conceptual capability—including proficiency in utilizing data and ability to formulate clear business questions that can be answered with data. 

• Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution.

• Communication Skills:  Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication.

• Project Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.

• Considers global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies.

• Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies.

• Fosters a culture in which people continually work to improve services, and work processes.

Key Responsibilities:

• Develop the Quality Performance 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.

• As part of the upstream protocol authoring process, partner with Drug Development, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.

• During trial conduct, provide feedback on risks to study specific critical to quality factors an