Director, Head of Compliance

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.

Education and Experience

• BS in relevant Science or Engineering discipline or MBA.
• Minimum of 12+ years of management experience in a regulated industry.
• Working knowledge across site quality roles including QA, QC, Quality Systems, validation, and regulatory.
• Proven experience managing global health authority inspections and remediation.
• Demonstrated experience building and leading exceptional teams.
• Proven leadership ability in matrixed environments.

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

Additional information

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

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.

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.

Data Protection

• We will never request payments, financial information, or social security numbers during our application or recruitment process.
• 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 with 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.

R1601370: Director, Head of Compliance