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.

Job description

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.

Requirements

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
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

Benefits

Medical, Dental & Vision
Life & Disability Insurance
Retirement Benefits
Financial Protection Benefits
Wellbeing Support
Flexible Time Off
11 Paid Holidays
Paid Sick Leave
Volunteer Days
Summer Hours Flexibility
Global Shutdown

Company overview

Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.