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Bristol Myers Squibb
Summit West - NJ - US; Summit West - NJ
Source: Bristol Myers Squibb careers · View original posting
From Bristol Myers Squibb's posting. “We” and “our” refer to the employer.
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.
Compensation
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.
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