Associate Director, Quality Risk Specialist

Position Summary

The Associate Director, RBQM – Hematology, Oncology, Cell Therapy, Immunology, Cardiology and Neuroscience will mainly be responsible for developing 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. They will provide quality and compliance consultation to clinical trials teams throughout the study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun.

Key Responsibilities

• 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.
• As part of the upstream protocol authoring process, partner with Drug Development, particularly the CORM function, to embed Quality by Design principles and help identify study‑specific CtQ data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.
• During trial conduct, provide feedback on risks to study‑specific CtQ factors and ensure mitigation strategies are adjusted for new or unanticipated issues.
• At the study level, conduct 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 quality and compliance consultation to clinical trials teams throughout the study lifecycle.
• 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/non‑compliance and important protocol deviations for CtQ data, processes and vendors.
• Support the 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 with project or products, to the business and Health Authorities, as needed.
• Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements.
• Engage externally with industry/trade/QA associations, regulatory agencies, vendors and licensing partners as needed.

Other

• Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation.
• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross‑functional level.
• Lead multidisciplinary or cross‑functional work/project teams; serve as part of strategic team(s) within the group/discipline.
• Lead and/or contribute to the implementation of large‑scale initiatives and/or organizational changes that affect the department.
• Act as a highly credible technical/functional expert; routinely provide technical/functional guidance/coaching to direct and indirect reports or peers.
• May influence the external environment through interactions with regulators, trade associations or professional societies.

Qualifications & Experience

• B.S. and/or M.S. in Chemistry, Biology, 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

• Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance.
• Extremely experienced in Risk Based Quality Management principles.
• In‑depth knowledge of applied risk‑management, including risk assessment, analysis, evaluation, reporting, communication, treatment and continuous review.
• Understanding of BMS’s therapeutic areas – Hematology, Oncology, Cell Therapy, Immunology, Cardiology and Neuroscience.
• Extensive experience in regulatory inspection preparation, management and 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.
• Excellent communication skills – professional, clear, concise and consistent both verbally and in writing; presentation skills for peer and Senior Management communication.
• Project Management – manage complex assignments and deliver all expected deliverables timely and proactively communicate changes.
• Considers global influences, situations and implications when making plans or decisions.
• Responds resourcefully to changing business conditions and opportunities.
• Fosters a culture that continually improves services and work processes.

Compensation Overview

Devens – MA – US: $175,310 – $212,438

Madison – Giralda – NJ – US: $163,850 – $198,543

New Brunswick – NJ – US: $163,850 – $198,543

Princeton – NJ – US: $163,850 – $198,543

The starting compensation range(s) above are for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities may be available depending on eligibility. Final compensation will be decided based on demonstrated experience.

Eligibility for specific benefits varies by job and location. For more on benefits, visit

Benefits

• Health Coverage: medical, pharmacy, dental and vision care.
• Well‑being support: programs such as BMS Well‑Being Account, BMS Living Life Better and Employee Assistance Programs (EAP).
• Financial well‑being and protection: 401(k), short‑term and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity‑theft benefit, legal support and survivor support.
• Paid time off: US Exempt Employees – unlimited time off with manager approval; 11 paid national holidays; Phoenix, AZ, Puerto Rico or Rayzebio exempt employees – 160 hours annual paid vacation for new hires, 11 national holidays and 3 optional holidays; other employees may receive unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, and various leaves of absence for medical, personal, parental, caregiver, bereavement and military needs.
• Global shutdown: all global employees full and part‑time who are actively employed at and paid directly by BMS on December 1 will be eligible for a global shutdown between Christmas and New Year’s Day.

Candidate Rights and Equal Employment Opportunity

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations and adjustments. Applicants can request accommodations before accepting a job offer. For accommodations inquiries, contact Visit careers.bms.com/eeo-accessibility for our full Equal Employment Opportunity statement.

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws. If you are or will work in Los Angeles County, please review for additional information.

We will never request payments, financial information or Social Security numbers during the application process. Learn more about fraud protection at

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