Associate Director, Quality Risk Specialist (GCP) – RBQM The Associate Director, RBQM 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.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.Partner with Drug Development during the upstream protocol authoring process to embed Quality by Design principles, identify study specific critical to quality (CtQ) data, processes and vendors, and ensure adequate risk mitigation strategies have been implemented.Provide feedback on risks to study specific CtQ factors during trial conduct and adjust mitigation strategies when new or unanticipated issues arise.Collaborate 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.Conduct quality assurance spot checks at the study level 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 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, ensuring effective management of significant quality issues/noncompliance and important protocol deviations for CtQ data, processes and vendors.Monitor and evaluate 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 relevant regulatory requirements.Engage externally with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.Drive quality into the business through proactive quality support, mentoring, 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 (such as functional optimization) that affect the department.Act as a highly credible technical/functional expert; routinely provide technical/functional guidance/coaching to direct and indirect reports/peers within the line or crosslines.Influence the external environment through interactions with regulators, trade associations, or professional societies.Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.Qualifications & 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.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.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.Excellent communication skills: professional, clear, concise, consistent both verbally and in writing; excellent presentation skills for peer and Senior Management communication.Strong project management ability to manage complex assignments/projects and 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.Responsive to changing business conditions and opportunities, proactively seeking ways the organization can adapt its plans, tactics, or strategies.Fosters a culture in which people continually work to improve services, and work processes.Compensation Overview – Full Time (FTE) Des Moines – MA – US: $175,310 - $212,438Madison – Giralda – NJ – US: $163,850 - $198,543New Brunswick – NJ – US: $163,850 - $198,543Princeton – NJ – US: $163,850 - $198,543Starting compensation ranges listed above for a full‑time employee. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final individual compensation will be decided based on demonstrated experience.Benefits Health Coverage: Medical, pharmacy, dental, and vision care.Wellbeing Support: BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).Financial Well‑being and Protection: 401(k) plan, short‑ 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.Work‑life Benefits: Paid Time Off, flexible time off (unlimited with manager approval), 11 paid national holidays (with some location exceptions), 160 hours annual paid vacation for new hires with manager approval, 3 optional holidays, unlimited paid sick time, optional volunteer days, summer hours flexibility, leaves of absence (medical, personal, parental, caregiver, bereavement, and military), and an annual Global Shutdown between Christmas and New Years.Equal Employment Opportunity Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For more detailed information, refer to BMS policies.#J-18808-Ljbffr