Executive Director, GxP Quality

Bristol Myers Squibb

. Establish and lead an enterprise-wide GxP Quality Center of Excellence covering GCP, GLP, and GVP .

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

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in GxP Quality Management Systems, regulatory compliance, and quality leadership within the pharmaceutical and biotech industries. Proven ability to drive organizational transformation, manage cross-functional teams, and implement risk-based quality strategies.

Highest-signal resume keywords

GxP Quality ManagementRegulatory ComplianceQuality LeadershipStakeholder ManagementRisk-Based Quality Engineering

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCPGLPGVPRegulatory FrameworksQuality by DesignCAPA ManagementRoot Cause AnalysisQuality Risk ManagementIND/NDA/MAA ManagementQMS Development

Soft Skills

Analytical SkillsCommunication SkillsExecutive Presentation SkillsPeople LeadershipCross-Functional Collaboration

Tools & Technologies

Veeva Vault QMSCTMSETMF

Industry Keywords

Pharmaceutical IndustryBiotech IndustryClinical DevelopmentRegulatory Authority InspectionsM&A Due DiligenceMedical DeviceDiagnosticsNovel Modalities

Tech Stack

Tools & technologies

Google Cloud PlatformVault

About the role

Key responsibilities & impact

Establish and lead an enterprise-wide GxP Quality Center of Excellence covering GCP, GLP, and GVP
Define and operationalize the GxP CoE strategy, capability model, roadmap, and operating model
Standardize best practices, tools, frameworks, quality processes, design controls, and lifecycle management across R&D Quality
Embed proactive, risk-based quality engineering, compliance, Quality by Design, lifecycle management, and continuous improvement
Partner with R&D, Product Development, Regulatory, Medical, Technology, Operations, and Global Quality stakeholders
Drive digital transformation, data-driven insights, advanced analytics, AI-enabled solutions, and operational effectiveness
Lead global inspection strategies, inspection management, regulatory readiness, health authority engagement, and inspection response governance
Oversee inspection observations, CAPAs, effectiveness evaluations, systemic remediation, and inspection outcomes
Establish and drive end-to-end GxP vendor quality oversight, risk segmentation, KPIs/KQIs, and governance
Lead investigations, root cause analysis, and CAPA management for internal and external quality events
Provide quality leadership for combination products, diagnostics, IVD, on-body delivery systems, and digital health technologies
Oversee design controls, human factors engineering, risk management, supplier quality, post-market surveillance, laboratory quality systems, assay validation, and diagnostic supplier quality
Support Business Development, Licensing, and M&A through GxP due diligence, risk assessments, mitigation strategies, and post-deal integration
Establish governance frameworks, councils, review boards, escalation forums, metrics, dashboards, and reporting
Act as Operational Lead for the R&D Quality Council and support Enterprise Quality Council content generation
Chair the GCP serious breach committee
Design, implement, and continuously improve a modern, harmonized R&D QMS
Oversee deviations, CAPAs, change control, quality events, training frameworks, knowledge management, and continuous learning
Lead RDQ strategic projects from initiation through execution, including timelines, budgets, and measurable outcomes
Provide leadership, coaching, development, performance management, and career planning for direct reports
Attract and retain quality talent and foster cross-functional collaboration
Represent BMS at external and cross-industry bodies
Manage team and RDQ budgets when applicable

Requirements

What you’ll need

Bachelor's or higher degree in a scientific discipline (Life Sciences, Pharmacy, Chemistry, or related field)
Advanced degree (MS, PhD, PharmD) strongly preferred
Minimum 15–20 years of progressive pharmaceutical/biotech industry experience
At least 10 years in Quality roles or equivalent within Development, Regulatory, or Quality Systems contexts
Deep knowledge of GCP, GVP, and other GxPs
Understanding of global regulatory frameworks, including ICH guidelines, FDA, EMA, MHRA, CFDA, and PMDA regulations
Proven track record leading or managing regulatory authority inspections and responding to inspection observations
Experience in regulatory activities, including IND/NDA/MAA and post-approval CMC change management
Demonstrated 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
Deep expertise across clinical, device, vendor, and QMS domains
Proven track record in organizational transformation, governance, and global program leadership
Strong understanding of regulatory expectations and inspection readiness frameworks
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
Experience in M&A due diligence and integration preferred
Exposure to medical device, diagnostics, and novel modalities is a plus
We hire for skills and capabilities, not just credentials

Benefits

Comp & perks

Comprehensive benefit plans
Wellbeing support
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
160 hours of paid vacation annually for eligible new hires
3 optional holidays for eligible non-exempt, RayzeBio, and Puerto Rico employees
Paid sick leave, depending on eligibility
Up to two paid volunteer days per year
Summer hours flexibility
Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
Annual Global Shutdown between Christmas Day and New Year's Day
Additional discretionary incentive cash
Stock opportunities
Workplace accommodations/adjustments and ongoing support
Opportunities for growth
Supportive, inclusive, flexible work environment
Training and knowledge platforms
Professional coaching, performance management, and career development opportunities