Associate Director, External Manufacturing Quality, Cell Therapy Global Quality

The Associate Director, External Manufacturing Quality, Cell Therapy is responsible for providing Quality oversight of Contract Manufacturing Organizations (CMOs) in support of Bristol Myers Squibb's product portfolio. This role requires expertise in GCTP/GMP compliance and Japan regulations, with a background in aseptic processing and strong leadership skills.

Requirements

• Provide QA oversight of CMOs such as Deviations, CAPAs, Change Controls, Batch Record Review, Lot disposition and CoT/CoA generation
• Ensure CMOs remain compliant with regulatory and internal procedures via annual risk assessments and routine/for-cause audits
• Proactively identifying risks and improvement opportunities and influencing decision-making for management
• Partner with CMO Quality to provide oversight of manufacturing operations and ensure work is performed in accordance with approved regulatory submissions, master service and/or quality agreements and applicable regulatory requirements
• Responsible for batch record review and product batch disposition
• Responsible for review and/or approval of CMO deviation investigations, CAPA, controlled documents (Master Batch Records)
• Act as QA impact assessor and approver of CMO related changes
• Responsible for review and approval of protocol/reports in support of regulatory submissions
• Responsible for review and/or approval of COI risk assessment and process map
• Responsible for quality risk assessment
• Develop and approve annual product review reports generated by CMOs
• Collaborate with Global Quality Systems and ensure CMO’s timely implementation of corrective actions resulted from BMS’s audits
• Assist in CMO GCTP/GMP audits, as required
• Influencing to key stakeholders internally and externally
• Support Management Review activities and oversee trending of key quality, product and GCTP/GMP metrics related to CMO
• Proactively provide teaching and coaching for junior team members
• Develop departmental goals and ensure timely completion of all deliverables

Benefits

• Competitive benefits, services, and programs that provide employees with the resources to pursue their goals, both at work and in their personal lives