Associate Director, Quality Risk Specialist

Associate Director, RBQM - HOCT, ICN 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.

The Associate Director, RBQM - HOCT, ICN will mainly be responsible for developing the Quality Narrative at the study and/or ASSET and TA 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 study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun.

• Develop the Quality 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.
• Partner with Drug Development during upstream protocol authoring to embed Quality by Design principles and identify study-specific CtQ data, processes and vendors, ensuring adequate risk mitigation strategies are implemented.
• During trial conduct, provide feedback on risks to study-specific CtQ factors and adjust mitigation strategies when new or unanticipated issues arise. This involves partnering with the CAPA CoE, Serious Breach pillar and Clinical Quality Assurance to gather input from audits, inspections, internal quality events, significant issues, and external intelligence to inform QbD.
• At the study level, conduct quality assurance spot checks to ensure risk mitigation strategies are accurately translated into operational plans.
• Assist the business in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data.
• Support for cause, critical and/or complex quality issues as well as serious breaches for the TA, where deemed necessary.
• Provide regulatory intelligence on current and upcoming regulations to ensure compliance with all applicable requirements.
• Establish strong partnership with business stakeholders.
• Partner with the study teams to manage significant quality issues/noncompliance and important protocol deviations for CtQ data, processes and vendors.
• Support monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt Quality plans accordingly.
• Provide R&D Quality expertise, critical thinking, deliver training and share best practices and lessons learned into future trials.
• Ensure rapid communication and escalation of quality issues, including potential misconduct or significant deviations, to the business and Health Authorities as needed.
• Ensure compliance with ICH (E8, E6, E9) and other regulatory requirements.
• Engage industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as needed.

• Drive quality into the business through proactive support, mentoring, coaching and consultation.
• Provide guidance and expectations to enable execution of external and internal regulations globally.
• Lead multidisciplinary or cross‑functional work or project teams; serve as part of strategic teams.
• Lead and/or contribute to large‑scale initiatives or organizational changes.
• Act as a highly credible technical/functional expert and provide coaching to peers and reports.
• May influence the external environment through interaction with regulators, trade associations, or professional societies.
• Share knowledge across multiple disciplines and lines through existing knowledge sharing processes and systems.

• B.S. and/or M.S. in Chemistry, Biology, Health or Quality related field or equivalent education, training, and experience.
• Minimum 8+ years QA…