Executive Director, GxP Quality Center of Excellence

At Bristol Myers Squibb our employees often ask Who are you working fora question that fuels collaboration accountability and urgency in our work. Our purpose-driven culture inspires us to discover develop and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work opportunities for growth and a supportive environment that values inclusion wellbeing flexibility and comprehensive benefits. This is work that transforms the lives of patients and the careers of those who do it.

Position Summary

The Executive Director GxP Center of Excellence (CoE) reports into VP R&D Quality. It is a strategic leadership role responsible for establishing and leading an enterprise-wide GxP (GCP GLP and GVP) quality capability that drives consistent data driven risk-ballanced practices and inspection readiness across R&D and associated functions. This role integrates vendor quality device quality GxP inspections CAPA and Investigation Excellence business development (M&A) governance QMS project management training and knowledge management into a unified CoE operating leader will ensure quality by design proactive risk management and regulatory compliance while enabling innovation speed and scalable growth across the portfolio. Through active participation in relevant governance forums this role oversees the identification escalation and mitigation of quality and compliance risks while driving continuous improvement operational effectiveness inspection readiness and quality culture.

The leader champions enterprise-wide quality transformation leveraging data-driven insights digital innovation and cross-functional collaboration to strengthen compliance enhance organizational capabilities and enable the efficient delivery of medicines to leader establishes and evolves the strategic vision roadmap and operating model for key quality capabilities with the CoE. Through continuous improvement digital innovation and operational excellence this role builds future-ready capabilities that strengthen compliance enhance organizational effectiveness and accelerate the delivery of innovative therapies to patients.

Key Responsibilities

Enterprise GxP CoE Leadership

• Define and operationalize the GxP CoE strategy aligned to enterprise objectives (People Performance Pipeline and Innovation).

• Establish a centralized capability model that standardizes best practices tools and frameworks across R&D Quality.

• Provide leadership in embedding proactive risk-based quality engineering compliance and lifecycle management from concept through post-market surveillance ensuring patient safety regulatory compliance and product quality throughout the end-to-end product lifecycle.

• Drive a risk-balanced data-driven quality culture across all GxP domains.

• Partner with R&D Product Development Regulatory Medical Technology Operations and Global Quality stakeholders to proactively identify assess and mitigate quality and compliance risks across combination products diagnostics and digital health technologies.

• Drive digital transformation to strengthen compliance streamline operating model and improve business outcomes

• Drive enterprise-wide quality excellence by embedding Quality by Design (QbD) risk-based decision making lifecycle management and continuous improvement principles

• Champion a right-first-time quality culture and continuous improvement mindset across the enterprise.

• Partner with RDQ pillars and relevant stakeholders to assure state of audit and inspection readiness and provide input into audit and inspection strategy and execution

Inspection Management and Readiness

• Provide strategic leadership and enterprise oversight for global inspection management and regulatory readiness ensuring a proactive risk-based approach to compliance health authority engagement and sustained inspection excellence across the R&D portfolio.

• Lead the development and execution of global inspection strategies across GCP GVP and GLP including:

  • Sponsor inspections

  • Investigator site inspection oversight

  • Global GLP inspections

  • Safety surveillance inspections

  • Pharmacovigilance system inspections

  • Affiliate and local authority inspections

  • Post-marketing lifecycle inspections

  • Regulatory authority engagements (FDA EMA PMDA NMPA MHRA and other global agencies)

• Establish and maintain a state of continuous inspection readiness through integrated risk assessment quality intelligence preparedness programs and proactive identification of emerging compliance risks.

• Oversee inspection response governance ensuring timely consistent and high-quality interactions with regulatory authorities including inspection preparation response strategy and commitment management.

• Provide executive oversight of inspection observations CAPAs effectiveness evaluations and systemic remediation efforts to ensure sustainable compliance and continuous improvement.

• Partner with senior leaders across Research Drug Development Global Quality and functional teams to drive accountability strengthen inspection preparedness and ensure end-to-end ownership of inspection outcomes.

• Leverage inspection intelligence regulatory trends and cross-industry learnings to identify enterprise risks inform strategic decisions and enhance organizational readiness.

• Define and advance a future-focused inspection operating model utilizing digital capabilities advanced analytics AI-enabled solutions and innovative approaches to improve efficiency scalability and regulatory compliance across the global portfolio

Vendor Quality Oversight

• Establish and drive an end-to-end GxP vendor quality oversight framework including qualification support quality oversight performance monitoring and risk management

• Ensure consistent application of GxP expectations across service providers CROs CMOs labs and strategic partners

• Deliver vendor risk segmentation KPIs/KQIs and governance mechanisms to proactively mitigate quality risks and improve quality/compliance.

• Support and partner across RDQ pillars in inspection readiness and audit readiness for all vendors

• Provide leadership to Quality Investigations Root Cause Analysis (RCA) and CAPA management for internal quality events and oversight of external quality events

Device Quality Integration

• Drive a data-driven innovative organization that simplifies complexity accelerates the device IVD and digital health pipeline and builds a culture where quality enables speed and fit-for-purpose compliance
• Drive the enterprise quality strategy governance and oversight for combination products diagnostics and digital health technologies across BMS partnering with key stakeholders
• Provide strategic quality leadership and oversight for combination products on-body delivery system (OBDS) platforms etc. ensuring robust design controls human factors engineering (HFE) risk management supplier quality and post-market surveillance throughout the product lifecycle
• Provide leadership in development and execution of quality strategies for in vitro diagnostics (IVD) including oversight of CLIA/CAP laboratory quality systems assay development and transfer analytical validation and diagnostic supplier quality management to ensure regulatory compliance and data integrity
• Represent Quality in governance forums and regulatory interactions providing strategic guidance on complex quality compliance product stewardship and patient safety matters related to devices diagnostics and digital health solutions.
• Continuously monitor evolving industry standards regulatory expectations (e.g. FDA EU MDR/IVDR/CDx etc.) and technology trends to develop future-ready quality capabilities that support innovation while maintaining the highest standards of quality compliance and patient trust
• Standardize device quality processes design controls and lifecycle management practices

Business Development (M&A) Quality

• Partner with Global Quality (GQ) and R&D stakeholders to provide input and GxP quality support for Business Development Licensing and M&A activities

• Define and execute GCP/GLP/GVP due diligence frameworks to assess quality risks compliance posture and integration complexity

• Provide clear risk assessments and mitigation strategies to inform deal decisions

• Provide leadership for post-deal integration of QMS processes and governance structures

• Create necessary playbook tools and templates to drive business success and sustainable operating framework

Governance & Quality Risk Management

• Establish and maintain robust governance frameworks to ensure consistent oversight escalation and decision-making

• Act as Operational Lead for R&D Quality Council and support Enterprise Quality Council content generation

• Drive and support relevant governance councils including vendor quality councils and Joint Operational councils

• Drive cross-functional alignment through quality councils review boards and escalation forums

• Define clear roles responsibilities and accountability across quality and business stakeholders

• Ensure transparency through standardized metrics dashboards and reporting

• Act as the GCP serious breach committee chair and provide leadership to related meetings and decisions

• Define relevant KPIs/KQIs as it pertains to assuring state of compliance and continupus improvement

• Provide strategic leadership and governance for R&D Quality Risk Management partnering across RDQ Global Quality and Drug Development

• Performance trend and signal detection for significant quality events investigations serious non-compliance Serious Breaches and CAPA management ensuring timely resolution sustainable corrective actions and effective regulatory engagement

• Drive continuous improvement of quality systems risk management frameworks and governance processes to enhance inspection readiness compliance performance and organizational effectiveness across R&D

Quality Management System (QMS) Excellence Training & Knowledge Management

• Provide leadership to the design implementation and continuous improvement of a modern harmonized R&D QMS.

• Ensure alignment with global regulatory standards (e.g. Pearl process ICH E6(R3) GxP regulations etc.)

• In partnership with relevant stakeholders drive simplification digitization and scalability of QMS processes

• Provide effective management of deviations CAPAs change control and quality events with a focus on root cause and prevention

• Establish a future-ready training and capability development strategy aligned to GxP requirements and evolving regulatory expectations

• Compliance oversight for R&D role-based training frameworks using relevant KPIs

• Implement knowledge management systems to enable reuse of best practices lessons learned and inspection insights

• Foster a continuous learning culture across R&D teams

CAPA and Investigation Excellence

• Provide vision and define the global CAPA strategy and governance model for Research & Development by establishing standard methods templates taxonomies and escalation pathways for quality events audits/inspections and significant non-compliances

• Design and implement a global CAPA governance framework aligned with regulatory expectations and internal quality standards

• Partner with RDQ Global Capability Center Lead in assuring CAPA-related performance metrics under GCCs responsibility are effectively managed

• Partners with key stakeholders across BMS including Senior Vice Presidents / Vice Presidents within Research Drug Development and Quality functions to influence stakeholders drive accountability and CAPA ownership at all levels

• Oversee the identification documentation and reporting of serious breaches in compliance with regulatory requirements and company policies ensuring timely and accurate communication to relevant authorities and stakeholders

Project Management

• Lead and drive RDQ strategic projects from initiation through execution ensuring alignment with BMS/GQ priorities timelines budget and measurable outcome

• Partner with GQ and R&D business functions to ensure alignment of strategic priorities and delivery to drive corporate goals

• Support budget management tiered management and relevant implementation of lean management principles for RDQ.

People Leadership & Organizational Development

• Provides leadership coaching and development for direct reports building organizational capability and cultivating a high-performing team aligned with strategic objectives.

• Build team capability through coaching performance management and career development planning.

• Model and reinforce a culture of quality accountability and psychological safety.

• Attract and retain top quality talent; resource the TA Quality function appropriately to meet portfolio demands.

• Foster a collaborative cross-functional partnership mindset within the quality team.

• Represent BMS at external and cross-industry bodies.

• Drive cross-functional collaboration and break down silos across R&D PDS and external partners.

• Budget Management for team and RDQ when applicable.

Core Competencies

• Strategic and enterprise mindset

• Risk-based decision-making and critical thinking

• Strong governance and execution discipline

• Stakeholder influence and executive communication

• Innovation and digital/AI-enabled quality transformation

Success Measures

• Standardized scalable GxP CoE operating model established

• Demonstrable improvement in quality metrics and inspection outcomes

• Effective integration of acquired assets with minimal quality risk

• High adoption of training programs and knowledge platforms

• Strong engagement and collaboration across global teams

• Reduction in repeat quality events and systemic issues

• Increased efficiency through standardized and digitized processes

• Enhanced vendor and partner performance

• Bachelors or higher degree in a scientific discipline (Life Sciences Pharmacy Chemistry or related field); advanced degree (MS PhD PharmD) strongly preferred.

• Minimum 1520 years of progressive pharmaceutical/biotech industry experience with at least 10 years in Quality roles or equivalent within Development Regulatory or Quality Systems contexts.

• Deep knowledge of GCP GVP and other GxPs including understanding of global regulatory frameworks (ICH guidelines FDA EMA MHRA CFDA PMDA regulations).

• Proven track record leading or managing regulatory authority inspections (FDA EMA or equivalent) 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 skills 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

Preferred

• Experience in a global biopharmaceutical organization with cross-functional matrix leadership.

• Familiarity with GxP quality systems (e.g. Veeva Vault QMS CTMS eTMF) and quality risk management methodologies (ICH Q9).

• Experience in M&A due diligence and integration preferred

• Exposure to medical device diagnostics and novel modalities (gene therapy cell therapy biologics or RNA-based therapies) is a plus.

Key Competencies

Leadership & Strategic Thinking-Technical Quality Expertise

• Drives quality vision and strategy

• Leads through ambiguity and complexity

• Develops and retains talent

• Influences senior stakeholders

• GxP regulatory knowledge (GCP/GVP/GLP)

• Inspection management expertise

• Risk-based quality management

• CMC and LCM quality oversight

Cross-Functional Partnership-Execution & Results Orientation

• Trusted advisor to TA and Medical Affairs leadership

• Effective communicator across organizational levels

• Collaborative yet decisive

• Prioritizes and manages multiple program demands

• Delivers quality outcomes on time

• Continuous improvement mindset

#LI- Hybrid

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully carefully considering the nature of the role required skills work location schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors and individual team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect you may be eligible to participate in our comprehensive benefit plans including wellbeing support retirement and financial protection benefits and insurance offerings (medical dental vision life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO) which provides paid time off without a set accrual limit subject to manager approval along with 11 paid company holidays each year.

Non-exempt employees RayzeBio employees and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval) 11 paid company holidays and 3 optional holidays.

Depending on eligibility employees may also have access to additional time-off benefits including paid sick leave up to two paid volunteer days per year summer hours flexibility and leaves of absence for medical personal parental caregiver bereavement or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Years Day.

U.S.-based job seekers can explore full benefit offerings at We Work

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