Senior Specialist, QA Operations Investigations

Working at Bristol Myers Squibb is a challenging and meaningful experience that can transform the lives of patients and the careers of employees. The company offers a wide range of competitive benefits and programs that provide employees with the resources to pursue their goals. The Senior Specialist, QA Operations Investigations role is responsible for reviewing and approving investigations and corrective actions at the company's cell therapy facility in Leiden, Netherlands.

Requirements

• Review and approve investigations / Corrective and Preventive Actions (CAPAs) / effectiveness checks associated with the manufacturing site
• Author, review, and approve technical reports to support the deviations program
• Ensure CAPAs are robust and adequately address the root cause
• Perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions
• Identify improvement opportunities and support execution of site/team continuous improvement goals and projects
• Support internal and external inspections as required
• Maintain compliance with assigned learning plan
• Support development and delivery of training content to cross-functional teams
• Lead meetings and represent function at cross-functional meetings
• Share data/knowledge within and across team
• Build and maintain strong relationships with partner functions

Benefits

• Competitive benefits and programs
• Flexible work environment
• Opportunities for career growth and development