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.
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
Qualifications
Specific Knowledge, Skills, Abilities:
Expertise in GCTP/GMP compliance and Japan regulations is required
Background in aseptic processing is required
Demonstrated excellence in written and verbal communication in both Japanese and English
Independent decision-making capability and ability to think conceptually and understand impact of decisions.
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
Proven strong leadership, logical thinking and demonstrated ability to engage/ influence team in a complex business situation
Advanced project management capabilities, Six Sigma methodologies, such as process mapping, root cause analysis,…