Director, Quality Excellence and Governance

Working with Us
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives. Read more: Summary

The Director of Quality Excellence and Governance is responsible for driving a culture of quality excellence across R&D Quality (RDQ) operations and ensuring robust governance of quality systems processes and performance.

This role will lead strategic initiatives to harmonize quality standards embed proactive and predictive quality principles and oversee governance frameworks that enable compliance operational efficiency and continuous improvement. The position serves as a key partner to senior leadership ensuring transparency accountability and alignment with global regulatory expectations and enterprise objectives. The role supports data-driven decision-making fosters cross-functional collaboration and promotes ongoing innovation. Additionally this position advocates for a culture focused on quality operational excellence and continuous improvement.

Key Responsibilities

Quality Strategy & Governance:

Provide strategic leadership to oversee the implementation and continuous improvement of the R&D Quality Risk Management framework ensuring effective roll-up and reporting of risks and insights to relevant governance forums.

Define and lead the R&D Quality Excellence and Governance strategy aligned with regulatory expectations industry standards and enterprise objectives.

Ensure alignment of Quality Strategy with ICH E6(R3) ICH E8(R1) Q9 BMS Quality Plan and applicable global regulations.

Lead the development and oversight of R&D Quality performance metrics to ensure effective consolidation and communication to Global Quality Drug Development Global Product Supply and Research as applicable in partnership with teams across RDQ.

Partner with Corporate Quality (CQ) and Global Quality (GQ) and maintain a RDQ quality governance framework including councils committees and escalation pathways.

Partner with GQ/CQ to oversee governance of quality policies standards and procedures ensuring alignment with ICH FDA EMA and other global regulations.

Monitor and report quality performance metrics RDQ compliance dashboards and risk indicators to senior leadership and enterprise governance bodies.

Quality Management System & Oversight:

Serve as a primary liaison for GQ and Drug Development to provide executive oversight of the R&D Quality Management System (QMS) ensuring scalability consistency and compliance with the BMS Quality Plan.

Partner with the GPO and BPO network to provide Quality input into Business Process Management and ensuring the QMS is fit for purpose for R&D.

Partner with RDQ LT and relevant pillars within RDQ to establish a mechanism for risk-based oversight models for clinical programs operations service providers and strategic partners.

Champion compliance with key ICH guidelines (e.g. E6 E8 E9 Q9) and other relevant regulatory requirements.

Influence senior stakeholders to embed quality ownership at all levels.

Risk Management & Continuous Improvement:

Drives Quality Risk Management solutions for RDQ in collaboration with RDQLT GQ and Drug Development.

Facilitate root cause investigations CAPA management and review/approval of CAPA plans as needed.

Drive continuous improvement initiatives to enhance quality processes systems and inspection readiness.

Develop and deliver training programs to enhance quality awareness and competencies across the organization as needed.

Ensure rapid communication and escalation of quality issues including potential misconduct or significant deviations to the business and Health Authorities as needed

Ensure effective identification mitigation and prevention of risks impacting subject safety data integrity and compliance

Lead and Support the GCP serious non-compliance management process including management of Serious Breaches leading investigations and development of CAPA plan.

Insights Metrics & Performance:

Collaborate with Global Quality Strategy and Business Excellence to set goals for RDQ that are specific measurable achievable relevant and aligned to the enterprise strategies and time bounded.

Partner with RDQLT and conduct comprehensive data analysis and interrogation of data to derive meaningful actionable insights that support data-driven decision-making and proactive signal detection for R&D Quality Council.

Provides clear actionable quality insights to senior leadership and governance committees.

Create a comprehensive plan that outlines the scope timeline resources and key milestones for strategic initiatives taking into consideration potential risk and mitigations.

Translate complex quality data into strategic insights highlighting systemic risks trends and opportunities

Provide routine and ad hoc quality consultation to study teams and other Drug Development functions as needed.

Provide coordination and support for R&D Quality Leadership Team meetings ensuring rigor in cadence agenda actions and follow-up if needed.

Other

Champion a Quality Mindset and oversee strategic planning processes such as setting clear initiatives developing strategic plans engaging stakeholders allocation of resources assigning clear responsibilities communication risk management continuous improvement etc.

Provide leadership for program governance operations and benefits realization such as but not limited to; successful attainment and utilization of the intended advantages outcomes or gains that were identified as part of the project objectives.

Encourage a culture of continuous improvement and innovation within the pillar and each strategic initiative to adapt to evolving industry trends and challenges.

Lead communication efforts and serve as a role model for company values.

Maintaining adoption connectivity and alignment with GPS GQ DD and Early Research & cross-functional partnership with key stakeholders such as Finance HR External Engagement BIT Communication and Change Management.

Establish strong partnerships with business stakeholders.

Track the external landscape and stay informed about industry practices and new regulations and developments in the risk management space.

Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline.

Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department.

Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.

Qualifications & Experience
Education and Experience:

• B.S. and/or M.S. in engineering scientific or related field.
• Subject matter expert in Drug Development related regulations standards best practices.
• PMP and/or Six Sigma / Lean certifications are preferred.
• Minimum 10 years in biopharmaceutical/life-sciences industries is preferred.

Required Competencies: Knowledge Skills and Abilities

• Proven experience in Quality Risk Management Operating Excellence Project Management and leading operations or continuous improvement teams.
• Demonstrated leadership skills including the ability to remove roadblocks establish priorities and maintain compliance sustainability.
• Leadership experience and effective communication with stakeholders at all levels along with a keen attention to detail.
• Exceptional strategic thinking abilities adept at managing complex systems navigating organizational politics fostering innovation and skilled in negotiation and management.
• Possesses a strategic perspective leading with vision and values exhibiting global acumen and displaying a strong leadership disposition.
• Strong customer focus interpersonal and organizational skills with a collaborative and teamwork-oriented mindset.
• Proven ability to manage multiple tasks in a fast-paced environment.
• Adept at working effectively across functional groups and teams to achieve objectives.
• Demonstrated competencies in influencing negotiating relationship management and a continuous improvement mindset.
• Budget management experience possesses an enterprise mindset making decisions and sharing resources for the greater benefit.
• Change agility with the ability to navigate ambiguity take calculated risks and lead others through change.
• Strong organizational and problem-solving abilities with a sense of urgency and the capacity to manage priorities and timelines effectively.

#LI-HYBRID

If you come across a role that intrigues you but doesnt 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.

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 employees 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 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 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.

*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.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 . Visit 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: Protection

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at 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 . 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.