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Position Summary

The Director Drug Product(DP) External Manufacturing QA is responsible for the Quality oversight of Contract Manufacturing Organizations (CMOs) and the Contract Testing Labs (CTLs) in support of BMS's product portfolio. "This role is accountable for routine Quality Assurance responsibilities related to the production, testing and disposition of cell therapy products (Drug Product) manufactured on behalf of BMS in Japan.

• This role will partner cross functionally with Global Product Quality (GPQ), External Manufacturing (ExM), Cell Therapy Technical Operations (CTTO), Analytical Science & Technology (AS&T), Supply Chain (SC), and teams within DP ,Vector External Manufacturing Operations to provide QA oversight of CMOs and CTLs including 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."
• Ensures CMOs and CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits leveraging Quality and risk-Based principles
  
  

Duties/Responsibilities

• Support the BMS on-boarding CMO process including Technology Transfer, Quality Agreement generation, business process definition and Quality oversight framework
• Provide guidance and direction to the CMC DP team on quality compliance and GMP systems requirements for products manufactured on BMS's behalf
• Build a team to support Drug product release
• Act as Quality Liaison with CMOs used for the manufacture of BMS's products, intermediates and critical starting and raw materials
• Support the transition of CMO operations from clinical to commercial production including process validation, inspection readiness activities (GMP assessments and mock PLIs), and systems remediations
• Responsible for batch record review and final DP disposition prior to Japan RP release. Develop and manage team responsible for disposition of the drug product.
• Responsible for ensuring disposition of product is carried out within acceptable and agreed turnaround times. Provide out of hours coverage as required
• Responsible for review and approval of CMO investigations, CAPA, controlled documents
• Act as QA impact assessor and approver of CMO related changes
• Responsible for data auditing, reviewing and approval of protocol/reports in support of JNDA submissions
• Collaborate with Quality Systems and ensure CMO's timely implementation of corrective actions resulted from BMS's audits
• Assist in CMO GMP audits, as required
• Support Management Review activities and oversee trending of key quality, product and GMP metrics related to CMO
• Participate in Material Review Board meetings and evaluate recommendations made by the board during product disposition
• Partner with Technical Operations for run the business activities
• Serves as the BMS Quality Ops single point of contact and is responsible and accountable for the quality and compliance performance of the assigned CMOs
• Develop and monitor Key performance indicators(KPI) and develop proactive management of dashboards and KPIs
• Oversee the Vendor Quality Management System to ensure Change Controls, Deviations, Customer Complaints, CAPA, Test Methods, Specification and improvement projects are managed in a compliant and timely manner
  
  

Reporting Relationship

• This role reports to Senior Director of Drug Product External Manufacturing Quality Services
• Will have direct reports
  
  

Qualifications

Specific Knowledge, Skills, Abilities

• Strong organizational skills, including ability to follow assignments through to completion""
• Ability to work in a high paced environment, meet deadlines, and prioritize work from multiple projects""
• Excellent verbal and written communication skills, and ability to work in an inter-disciplinary and cross-function team""
• Detail-oriented with demonstrated applications in problem solving"and solid decision-making abilities.
• With moderate oversight from Manager, think strategically and understand global impact of decisions"
• Ability to manage and communicate at multiple levels of management""
• Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition
  
  

Education/Experience/ Licenses/Certifications

Education

• Bachelor's degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas."
  
  

Experience

• A minimum of 12 years' experience in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility
• Hands-on experience with QA oversight of contract manufacturing organizations is highly desired, but applicable Quality Assurance experience will be considered
• Experience with QA oversight of Cell Therapy Durg product manufacturing, Cellular Therapeutics and/or gene-based products and biologics is preferred
• Knowledge of applicable PMDA regulations in the biotechnology industry Experience managing external suppliers and other supply chain issues and have experience of working under USFDA and EMA regulations
• Experience in building and growing an organization into a high performing team
• Excellent communication, troubleshooting, and problem-solving skills
• Strong team player, who can work independently to achieve objectives
• Ability to work effectively at a fast pace
• Excellent verbal and written communication skills
• Soft skills negotiating and influencing
  
  

Travel

• This position requires up to 20% of travel - Domestic and International
• Work from CMO site as required
  
  

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.

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.

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

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