Sr. Manager, Ex Material Supplier Quality

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position

Manager (EG-120), QA Engineering

Manager

Associate Director (EG-140), QA Engineering

Prerequisites (As Applicable)

Minimum B.S. degree required with minimum 8 years of experience in the pharmaceutical or related industry, including 4-6 yrs. of Supplier Quality Oversight

Location

Summit, NJ (and/or Seattle, WA)  

PURPOSE AND SCOPE OF POSITION:

This position provides quality oversight for material suppliers and vendors used to manufacture, package and test BMS clinical and commercial cell therapy products (“BMS CTDO”) in accordance with policies, standards, procedures, and international cGMP’s. The incumbent will be responsible for the approval activities related to various suppliers including raw material, consumable, external labs, transportation suppliers, etc. used for the manufacture, package and testing of CAR-T products. To the latter, the incumbent will also have additional responsibilities that include but are not limited to, providing quality support to internal BMS stakeholders and SMEs, reviewing/ approving product related GMP documents, authoring supplier quality system documents.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Thorough knowledge of cGMP in the pharma/Biotech industry as well as FDA, EU, and JP regulatory requirements, ICH guidelines.
• Knowledge of cell therapy manufacturing processes and testing is preferred.
• Good knowledge of sterile products manufacturing processes and testing. Knowledge of aseptic manufacturing processes
• Experience with performing/participating in risk assessment exercises.
• Experience in Supplier Quality oversight.
• Thorough knowledge of and competence in core quality processes - including change control, deviations/OOS, CAPA management, investigations, APR-PQR.
• Excellent investigational and QA problem solving skills – e.g.
  • -Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
  • Able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.
  • Must have strong authorship and be able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.
• Analytical mindset – e.g.
  • Able to assess vendors quality core processes to ensure compliance with relevant guidelines and procedures; able to identify acceptable mitigation actions.
  • Able to recognize quality risks and develop contingency plans.
  • Able to assess, establish and implement new quality processes both internally and in partnership with assigned vendors. Able to author resulting procedures and tools.
  • Able to recognize patterns in reported data and communicate strategic solutions to stake holders cross-functionally.
• Quality performance / continuous improvement oriented – e.g.
  • Able to create and maintain meaningful metrics for assigned activities.
  • Able to recognize trends in product data and results.
  • Able to assess and recommend improvement measures to processes; able to drive implementation accordingly.
• Good understanding of batch disposition principles, aligned with QP concept and associated duties including liaison with Health Authorities.
• Skilled in planning and organizing, building relationships, innovation management and resource allocation.
• Ability to make independent and objective decisions and to work under minimal supervision with cross functional teams and partners worldwide.
• Team spirit. Action-oriented and customer-focused.
• Negotiation and persuasion skills.