Director, Head of Compliance

Bristol-Myers Squibb Co; Bend (OR); On-site; USD 188,000 - 227,000; Full time

Benefits offered by this job

Comprehensive benefits

Stock opportunities

Discretionary incentive bonus

Job summary

Bristol Myers Squibb is seeking a Director of Quality Compliance for the Summit West Cell Therapy Manufacturing Facility in Summit, NJ. You will lead the development and execution of site compliance programs, drive internal audits, health authority inspections, and risk management to ensure inspection readiness.

The role reports to the Senior Director, Quality Systems & Compliance and requires strong cross-functional leadership, strategic thinking, and experience with regulatory requirements in

Qualifications

• Must build strong, trusting relationships across divisions and cultures

Responsibilities

• Oversee end-to-end site preparation and management of audits and regulatory inspections
• Lead internal audits of facility, warehouses, and labs
• Manage health authority inspections (FDA, EMA, Health Canada, PMDA)
• Develop and maintain site compliance risk register and KPI oversight
• Communicate status of quality events to senior leadership
• Develop BPDRs, product defect notifications, and drug shortage notifications
• Own Site Compliance Plan aligned with quality objectives
• Develop budgets, metrics, and staff development

Education

MS in relevant Science or Engineering discipline

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a 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 Director, Quality Compliance at the BMS Summit West Cell Therapy (CAR T) Manufacturing Facility in Summit, NJ is responsible for the development, implementation, enhancement, and continuous improvement of site Compliance. The role will work collaboratively across BMS to ensure that all site Compliance programs are successful in maintaining high standards of quality compliance. The position oversees all aspects of site Compliance and readiness, including leading internal audits of the manufacturing facility, warehouses, and labs; managing health authority inspections (e.g. FDA, EMA, Health Canada, PMDA); maintaining a site compliance risk register; proactively identifying site compliance events or trends; conducting gap assessments against standards and regulations; leading fact-finding meetings; communicating the status of significant quality events to senior leadership; authoring health authority compliance notifications (e.g. Biological Product Deviation Reports (BPDRs), EU Product Defect Notifications and Recalls); and ensuring that the site maintains a constant state of inspection readiness.

This role is stationed in Summit, NJ, and reports to the Senior Director, Quality Systems & Compliance.

Requirements

Ability to build strong, trusting relationships and lead large/complex programs across divisions, diverse business backgrounds, and cultures. Excellent communication and interpersonal skills with internal and external stakeholders at all levels. Strategic thinker with strong business acumen and end-to-end enterprise mindset. Excellent influencing and negotiating capabilities in a matrix environment. Ability to interact with senior leaders as a credible and trusted partner. Strong project management and execution skills; ability to manage multiple priorities. Proven track record of delivering results and action-oriented leadership. Adapts to changing work environments, priorities, and organizational needs. Leads within broader networks to impact organization-wide performance. Embraces complexity while striving for simplicity. Generates trust through consistency of words and actions. Demonstrated quality leadership through cross-functional partnership and KPI oversight.

Preferred Qualifications

MS in relevant Science or Engineering discipline. Experience in CAR T, Pharma, or Biologics. Experience in continuous improvement, operational excellence, or Six Sigma.

Duties and Responsibilities

Oversee and host end-to-end site preparation and management of corporate audits and regulatory inspections. Lead and host Fact Finding meetings for significant events and ensure QMS documentation. Manage NTMs, BPDRs, Product Defect Notifications, and Drug Shortage Notifications. Identify and trend quality and compliance risk signals. Develop and oversee execution of site internal audit program. Lead site Quality Risk Management and Data Integrity programs. Own the Site Compliance Plan aligned with strategic quality objectives. Develop departmental goals, budgets, metrics, and succession plans. Provide direction, oversight, and development of staff. Ensure compliance to Quality Risk Management and Data Integrity.

Compensation Overview

Summit West - NJ - US: $187,700 - $227,445. 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 Year's Day. U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: 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: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.