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.

Position: Manager, QA Manufacturing Operations

Location: Devens, MA

Shift Friday, Saturday and Sunday 12 hour shift 7am to 7pm

Key  Responsibilities:

• Establish and communicates performance objectives for Quality Assurance staff that are consistent with the 
business’ unit goals, Quality and Technical Operations objectives. 
• Provide quality floor support of complex manufacturing issues 
• Defines and enforces performance measures, provides developmental feedback and coaching and creates a 
collaborative environment enhances unit performance and integration across site departments. 
• Hires, integrates and develops high quality talent, capable of delivering against the department’s goals and 
objectives. 
• Provides quality oversight of manufacturing activities on a day-to-day basis and provides oversight of the review and approval of minor changes to master batch recipe records. 
• Performs review and approval of Quality, Manufacturing, and Material Specification SOPs and documents. 
• Provides oversight to Quality walkthroughs for shutdown and inspections readiness activities and ensures program 
management is in compliance with site and corporate procedures. 
• Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products. 
• Reviews, approves and provides guidance for quality master data. Responsibilities include updates to Drug 
Substance lot status in applicable quality systems. 
• Directly participates in internal audits or reviews as well as global health authority inspections. May include 
representation on inspection response and CAPA teams. 
• May provide Quality review and approval of investigation records and CAPA, records. 
• Provides for strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement. 
• May act as delegate for QA Operations Manager for departmental meetings, projects and tasks. 
• Supervises up to 6 employees overseeing quality floor support of manufacturing

• Key Core behavioral indicators for this role include participation in the creation of a team-based environment, 
promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals. 
• Demonstrates appropriate examples of compliance behaviors and attitudes.

Qualifications & Experience

•  Specialist: A M.S. with 4-6 years of relevant experience within the pharmaceutical or healthcare industry, or a B.S. with 7-9 years of relevant experience within the pharmaceutical or healthcare industry; including 2-4 years experience in a regulated function.
• Experience in a R&D environment is an asset.
• Strong knowledge of pharmaceutical processing techniques.
• In-depth knowledge of GMP regulations.
• Strong interpersonal and organizational skills.
• Demonstrated leadership skills.
• Computer literacy: Microsoft Office and SAP environment Quality management system, Veeva, PDLIMS, and other systems as required (e.g. DeltaV, PilotClean).
• Decision-making regarding disposition for distribution of clinical trial materials and materials for production, based on documentation review.
• Decision-making where commitment is required on release dates for product and/or material.
• Works to resolve problem that may arise when a product or material needs to be released in a short time frame and documents received are incomplete and/or contain errors.
• Demonstrates initiative to clarify unclear