Bristol Myers Squibb · 2 days ago
Associate Director, Quality Risk Specialist
Madison, NJ
Full-time
Hybrid
Lead/Staff, Director/Executive
$175K/yr - $212K/yr
8+ years expBristol Myers Squibb is a company dedicated to transforming patients' lives through science. The Associate Director, Quality Risk Specialist will be responsible for developing the Quality Narrative for clinical trials, providing quality and compliance consultation, and ensuring effective risk management throughout the study lifecycle.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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, 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 and ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun. This will involve partnering with the CAPA CoE and 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 quality and compliance consultation to clinical trials teams throughout study lifecycle
Provide regulatory intelligence on current and upcoming regulations to ensure we remain compliant with all applicable requirements
Establish strong partnership with business stakeholders
Partner with the study teams to ensure effective management of significant quality issues/noncompliance 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 issues of significant deviations with project/products, to the business and Health Authorities, as needed
Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements
External engagement as needed 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 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 (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
May 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
Qualification
Required
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 - HOCT and ICN
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
Benefits
Health Coverage Medical, pharmacy, dental, and vision care.
Wellbeing Support Programs such as 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.
Paid Time Off
US Exempt Employees flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Eligibility Disclosure T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-09
2026-01-08
2026-01-07
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