Senior Specialist, Quality Systems, LPO

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. 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.

The Senior Specialist for Quality Systems at the S-12 Cell Therapy Manufacturing is responsible for the oversight and management of the Corrective and Preventive Action (CAPA), Supplier Corrective Action Request (SCAR), Change Control, Deviation and complaints processes. In this role, the incumbent will serve as local process owner (LPO) for the CAPA, SCAR, Change Control, Deviation, Complaint modules and the associated governing local procedures and supporting processes.  This highly visible position requires cross-functional collaboration and has a direct impact on site quality performance and continuous improvement initiatives.

Key Responsibilities:

• Manages Change Control, CAPA, Deviation, SCAR, and Complaint Quality Systems for all GMP activities and works with responsible cross functional areas ensure timely completion.
• Run the Change Control Process, CAPA, Deviation Review Board, generate meeting minutes, follow up on action items and facilitate resolution when required
• Compiles applicable process metrics, identifies trends and escalates accordingly
• SME support during internal and health authority inspections of facility
• Communicates effectively with cross functional stakeholders on matters related to change control process
• Review and approve CAPA, and Change Controls
• Supports Quality Systems harmonization efforts.
• Performs other tasks as assigned by manager.

Qualifications & Experience:

• College or university degree required.
• 4-7 years of experience in cell therapy, pharmaceutical or related industry
• An equivalent combination of education and experience may substitute

• Must have experience with cGMP manufacturing, Quality, and Compliance.
• Must have strong authorship and be able to critically evaluate change controls and generate technical conclusions consistent with Quality risk management principles.
• Must be able to routinely recognize quality issues and interpret problems, as well as propose solutions for complex issues. 
• Must understand continuous improvement and be able improve the compliance and efficiency of the quality system.
• Must be able to effectively prepare and convey data analysis to management and others within the group with clarity and accuracy.
• Must be self-directed, complete routine tasks independently and be confident in making decisions in respective subject matter area, consulting with management for decisions outside of established processes.
• Requires moderate direction to complete more complex tasks
• Comfortable providing input/guidance to others within the department and across the organization in change control technical writing.
• Propose solutions for issues and work with management to resolve.
• Comfortable providing training/guidance to system users as needed, and in instructor-led settings.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to support internal and health authority inspections of facility.

LI-Onsite

BMSCART

VETERAN

GPS_2025

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.

Compensation Overview: