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Associate Director, External Manufacturing Quality, Cell Therapy Global Quality
- 給与
- 記載なし
- 勤務地
- 記載なし
- 休日
- 記載なし
- 雇用形態
- 記載なし
どんな仕事かAIによる生成
Provides Quality oversight of CMOs, Contract Testing Labs and, if applicable, Logistics Service Providers supporting BMS’s cell therapy product portfolio. The role oversees CMO quality systems and manufacturing operations, including batch review and disposition, deviations, CAPAs, changes, audits, regulatory inspection readiness, and ongoing quality improvement.
この求人に応募
応募資格
必須
- 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.
- 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.
歓迎
- Experience with overseeing GCTP/GMP operations in a commercial CMO manufacturing facility is preferred
- Continuous improvement, operational excellence, and Six Sigma experience preferred.
応募について
- 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.
募集要項最終確認 10/21
- 職種
- 品質管理
- 雇用形態
- 記載なし
- 役職
- Associate Director
- 給与
- 記載なし
- 勤務地
- Otemachi-JP
- 働き方
- 記載なし
- 経験年数
- 10年以上
- 学歴
- 大学卒業以上
- 掲載日
- 2026/10/12 08:00（10日前）
- 最終確認
- 2026/10/21 15:47（1日前）
仕事内容
募集内容
- 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
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