Associate Director, External Manufacturing Quality, Cell Therapy Global Quality

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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

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.

Travel

• This position requires travel to CMO

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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

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R1599748 : Associate Director, External Manufacturing Quality, Cell Therapy Global Quality