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, and effective problem-solving techniques.

 

Education/Experience/ Licenses/Certifications:

• Master’s or bachelor’s in biochemistry, biology, microbiology, chemistry, engineering, pharmacy, or a related field.
• At least 10 years of experience in the biotech or pharmaceutical industry, including a minimum of 5 years overseeing Quality Assurance in a commercial manufacturing facility for Biologics or Cell Therapy drug products.
• Experience with overseeing GCTP/GMP operations in a commercial CMO manufacturing facility is preferred
• Continuous improvement, operational excellence, and Six Sigma experience preferred.

 

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:  If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606688 : Associate Director, External Manufacturing Quality, Cell Therapy Global Quality