Director, Head of Compliance

Bristol Myers Squibb•Summit, NJ

1d•$187,700 - $227,445•Onsite

About The Position

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.
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.

Nice To Haves

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

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

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays
160 hours of paid vacation annually
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day