■Position Summary
The Associate Director, APAC External Manufacturing Quality, Cell Therapy is responsible for providing Quality oversight of Contract Manufacturing Organizations (CMOs), Contract Testing Labs (CTLs), Logistics Service Provider if applicable in support of BMS’s product portfolio under the Director of the function (APAC External Manufacturing Quality, Cell Therapy).

This role is to:
・Provide QA oversight of CMOs such as Deviations, CAPAs, Change Controls, Batch Record Review, Lot disposition and CoT/CoA generation to support the clinical and commercial release of Drug product in a timely manner. 
・Ensure CMOs remain compliant with regulatory and internal procedures via annual risk assessments and routine/for-cause audits leveraging Quality and risk-Based principles.
・Proactively identifying risks and improvement opportunities and influencing decision‑making for management to ensure business continuity, regulatory success, and sustainable growth.



■Duties/Responsibilities
・Provide Quality Oversight of technology transfer and routine GCTP/GMP operations at CMOs in support of cell therapy intermediate product manufacturing.
・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.
・Provide quality compliance guidance and oversee readiness for pre-license inspection including the remediation of any GCTP/GMP deficiencies in order to ensure a timely approval and commercial launch
・Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of CMO oversight program
・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

■Reporting Relationship ​
Director, APAC External Manufacturing Quality, Cell Therapy