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Position Summary
Director, Development Quality - Neuroscience, will mainly be responsible for designing, developing and implementing risk-based quality management strategies to identify, assess and mitigate risks throughout the clinical trial process. This ensures compliance with regulatory requirements, maintains the reliability and interpretability of trial results, safeguards patient safety and upholds the quality of study data.
Key Responsibilities
Ensure Quality Strategies for the Neuroscience portfolio are developed to avoid, detect and address serious non‑compliance with GCP, the trial protocol and applicable regulatory requirements to prevent recurrence.
Oversee development of the Quality Narrative (or equivalent) at the ASSET / TA level, to document the end‑to‑end risk‑based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.
Manage a team of Asset Quality Leads and oversee team performance, provide guidance and development opportunities, ensuring operational efficiency and alignment with departmental and organizational objectives.
Partner with the Drug Development organization to drive adoption of Quality by Design principles across BMS protocols to ensure quality is built into the scientific and operational design and conduct of clinical trials.
Ensure risks to critical to quality factors are managed prospectively and adjusted when new or unanticipated issues arise once the trial has begun.
Provide leadership, guidance, development and coaching to the R&D Risk Management team for management of significant quality issues.
Lead for‑cause, critical and/ or complex quality issues as well as serious breaches for the TA, if needed.
Provide R&D Quality expertise, critical thinking and partner with Drug Development to deliver training and education (e.g., use cases, best practices, road shows, etc.) to support effective RBM practices.
Establish strong partnerships with business stakeholders and participate in GPT / CDT / other relevant governance committees for the ASSET. Preferably from ID‑2 (Go to Development) or ID‑3 (Go to POC).
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.
Define, own, and execute R&D Quality processes contributing to Drug Development’s end‑to‑end Risk Management framework across the clinical trial portfolio.
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.
Other Responsibilities
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.
Qualifications & Experience
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.
Education and Experience
Neuroscience experience is 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 10+ 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 - 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.
If you come across a role that intrigues you but does not perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview
Devens – MA – US $200,840 – $243,368
Madison – Giralda – NJ – US $187,700 – $227,445
Princeton – NJ – US $187,700 – $227,445
The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job‑related knowledge and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
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.
Work‑Life Benefits
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.
Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part‑time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
Eligibility Disclosure: The 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.
Supporting People With Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https://careers.bms.com/california-residents/.
Data Protection
We will never request payments, financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
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