Ensure Quality Strategies for 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.
Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation.

Requirements

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.
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.

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.
Work-life benefits include: 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 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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Quality AssuranceRisk Based Quality ManagementRegulatory ComplianceClinical DevelopmentRisk AssessmentRisk AnalysisRisk EvaluationRisk ReportingRisk TreatmentQuality Management

Soft Skills

LeadershipCoachingGuidanceAnalytical SkillsProblem-SolvingCommunicationCollaborationCritical ThinkingMentoringOperational Efficiency