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Position Summary:

• To provide Quality oversight of Contract Manufacturing Organizations (CMOs) in support of BMS’s Cell Therapy operations in Japan.
• To partner and provide support to the Responsible Person for Quality Assurance with respect to drug product disposition and distribution in Japan.

Duties/Responsibilities

• Provide Quality oversight of routine operations at CMOs in support of cell therapy (CAR-T) 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.
• Responsible for batch record review for disposition
• Responsible for review and/or approval of CMO deviation investigations, CAPA, controlled documents (Master Batch Records)
• Act as QA impact assessor and reviewer/approver of CMO related changes
• Responsible for review and/or approval of COI risk assessment and process map
• Responsible for quality risk assessment
• Support in data auditing and review of protocol/reports in support of regulatory submissions
• Develop and review/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
• Partner with stakeholders across different operational functions to define projects in order to improve processes and represent the quality organization in implementation phase
• Drive, lead and oversee quality related improvement projects in collaboration with affected CMO functions
• Support in setting and follow up of CMO related key performance indicators (KPI) and metrics
• Provide Quality oversight of routine operations for distribution center responsible for disposition and distribution of finished cell therapy product (CAR-T) in Japan
• Partner and provide support to the Responsible Person for Quality Assurance of commercial product (Hinseki) with respect to finished drug product release for Japan

Reporting Relationship

Director, Drug Product External Manufacturing Quality, Cell Therapy Global Quality

Qualifications

• Specific Knowledge, Skills, Abilities:

REQUIRED

• Strong organizational skills, including ability to follow assignments through to completion.
• Advanced skills in leading, influencing, and negotiating in order to manage CMOs appropriately.
• Advanced knowledge of relevant regulations and guidance; available to act as a resource for colleagues.
• Independent decision-making capability and ability to think conceptually and understand impact of decisions.
• Flexibility in responding to change or business needs
• Advanced verbal and written communication skills in Japanese and English.
• Ability to work in cross functional teams

PREFFERED

• Experience within the Cellular Therapeutics environment

• Experience with Commercial products and clinical products

• Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition

• Ability to prioritize and successfully manage complex and competing projects

• Detail-oriented with expertise in problem solving and solid decision-making abilities

• Ability to work in a fast-paced environment

• Education/Experience/ Licenses/Certifications:

Master’s degree or bachelor’s degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas.

REQUIRED

More than 5 years’ experience in regulated environment (cGMP/GCP/GCTP) with a minimum of 3 years’ experience in quality assurance.

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.

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 for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1598556 : Manager, Japan QA Operations CAR T