Executive Director, Development Quality

Bristol Myers Squibb

. Provide strategic and operational quality leadership across all therapeutic areas from first-in-human through lifecycle management .

Posted 9/16/2026full-timePrinceton • New Jersey • United StatesLead💰 $260,860 - $316,097 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Quality Leadership across therapeutic areas, ensuring GxP compliance and inspection readiness while driving quality oversight strategies. Proven ability to manage regulatory inspections and lead high-performing quality teams in a global biopharmaceutical environment.

Highest-signal resume keywords

GxP ComplianceQuality Oversight StrategyRegulatory Authority InspectionsQuality Risk ManagementStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemsRegulatory SubmissionsCAPA ManagementRoot Cause AnalysisQuality MetricsIND/NDA/MAA ActivitiesGCP KnowledgeCMC Change ManagementQuality InvestigationsTherapeutic Area Oversight

Soft Skills

LeadershipCoachingCommunicationAnalytical SkillsInfluencing Skills

Tools & Technologies

Veeva Vault QMSCTMSETMF

Industry Keywords

PharmaceuticalBiotechGlobal Regulatory FrameworksICH GuidelinesFDA RegulationsEMA RegulationsMHRA RegulationsCFDA RegulationsPMDA RegulationsGene Therapy

Tech Stack

Tools & technologies

Google Cloud PlatformVault

About the role

Key responsibilities & impact

Provide strategic and operational quality leadership across all therapeutic areas from first-in-human through lifecycle management
Oversee GxP compliance, inspection readiness, and quality culture across the development portfolio
Serve as accountable Quality partner to Global Drug Development and Global Development Operations
Define and drive therapeutic-area Quality oversight strategy
Drive Trial Quality Health through Trial Quality Performance Narratives and GCP Consultation
Provide proactive quality guidance and risk-based oversight to therapeutic-area, Drug Development, Clinical Operations, Regulatory Affairs, and Medical Affairs leadership
Oversee quality risk assessments and escalation management for high-impact program decisions, regulatory submissions, and post-approval changes
Represent R&D Development Quality at governance bodies and drive resolution of quality and compliance risks
Ensure inspection readiness through proactive oversight, mock inspections, and CAPA management
Lead quality investigations, root cause analysis, and CAPA management for quality events
Oversee the GRS Quality Business Partner and quality integration into regulatory strategy, CMC submissions, and applicable manufacturing changes
Oversee complex CMC/GRS issues, including out-of-specification investigations, manufacturing deviations, and regulatory agency queries
Support data quality standards in RIM systems and related metrics
Provide oversight and strategic direction for Medical Affairs and Lifecycle Management Quality Business Partnerships
Embed quality oversight in non-interventional studies, health economics, patient support programs, post-approval programs, and medical affairs operations
Assure QMS compliance for Medical Affairs-sponsored studies, patient support programs, and real-world evidence activities
Lead quality review and oversight of promotional and medical affairs materials where required
Partner on audit and continuous inspection readiness across therapeutic-area programs and Medical Affairs/Lifecycle Management portfolios
Prepare for and manage FDA, EMA, PMDA, and other global health authority inspections
Serve as primary quality contact during regulatory inspections and manage responses to observations and audit findings
Track and trend inspection outcomes, quality events, and audit findings to drive systemic improvements and CAPA effectiveness
Oversee quality systems for development, patient support programs, and medical affairs, including deviation management, CAPA, change control, and vendor qualification
Establish and monitor quality metrics and KPIs; present quality performance and risk to senior leadership and governance bodies
Escalate critical quality issues to senior Quality and GDD/GDO leadership
Provide leadership, coaching, and development for direct reports
Build team capability through coaching, performance management, and career development planning
Attract and retain quality talent and resource the therapeutic-area Quality function
Foster collaborative cross-functional partnerships
Represent BMS at external and cross-industry bodies
Manage team and R&D Development Quality budgets when applicable

Requirements

What you’ll need

Bachelor's or higher degree in a scientific discipline (Life Sciences, Pharmacy, Chemistry, or related field)
Minimum 15–20 years of progressive pharmaceutical/biotech industry experience
At least 10 years in Quality roles or equivalent within Development, Regulatory, or Medical Affairs contexts
Experience providing quality oversight across multiple therapeutic areas and development phases from FIH through NDA/MAA and post-approval
Deep knowledge of GCP, GVP, and other GxPs
Understanding of global regulatory frameworks, including ICH guidelines and FDA, EMA, MHRA, CFDA, and PMDA regulations
Track record leading or managing regulatory authority inspections and responding to inspection observations
Experience with IND/NDA/MAA regulatory activities and post-approval CMC change management
People leadership experience, including building and developing high-performing quality teams
Exceptional stakeholder management and ability to influence without authority at senior levels
Strong analytical, communication, and executive presentation skills
Advanced degree (MS, PhD, PharmD) strongly preferred
Experience in a global biopharmaceutical organization with cross-functional matrix leadership preferred
Familiarity with GxP quality systems such as Veeva Vault QMS, CTMS, and eTMF preferred
Familiarity with quality risk management methodologies such as ICH Q9 preferred
Prior Quality Business Partner experience embedded within a therapeutic area or development organization preferred
Exposure to gene therapy, cell therapy, biologics, or RNA-based therapies is a plus

Benefits

Comp & perks

Additional discretionary incentive cash and stock opportunities
Wellbeing support benefits
Retirement and financial protection benefits
Medical, dental, vision, life and disability insurance offerings
Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees
11 paid company holidays annually
160 hours of paid vacation annually for eligible new hires in specified employee categories
3 optional holidays for eligible employees in specified employee categories
Paid sick leave, depending on eligibility
Up to two paid volunteer days per year, depending on eligibility
Summer hours flexibility
Medical, personal, parental, caregiver, bereavement, or military leaves of absence
Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees
Reasonable workplace accommodations/adjustments
Opportunities for growth and a supportive, inclusive workplace environment