Senior Specialist, QA Shop Floor M-F, Cell Therapy

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.

About the role

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position works a Monday to Friday schedule, Day shift. The Senior Specialist, Shop Floor QA, will oversee and partner with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. In this capacity, the Senior Specialist will serve as a Shop Floor Representative interacting with Manufacturing, Supply Chain, Quality Control, and other supporting teams.

The role involves monitoring and tracking process performance related to key Shop Floor quality assurance tasks and operational tasks through data and analytics; owning, reviewing, or approving Floor Quality GxP records including procedures, CAPAs, change controls, impact assessments, documentation, or deviations; and representing Shop Floor QA at relevant governance forums. The incumbent will also support deviation approval, alarm approval, other Quality System Records, or batch record review as requested by management.

Effective communication, critical thinking, and a thirst for knowledge are foundational skills for success in this role. This is an individual contributor position reporting to the Senior Manager, Quality Assurance Shop Floor Monday to Friday Team.

Responsibilities

• Provide Quality oversight to Manufacturing, QC, Warehouse, and Packout operations.
• Identify departures from approved procedures and respond to complex issues independently; escalate critical issues to management.
• May perform and document operational verification per approved procedures.
• Develop, review, and/or approve temporary and non-routine procedures for event response.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Coordinate and lead area walkthroughs to identify quality issues; negotiate remediations and drive alignment of implementation plans.
• Own actions for departmental programs and propose improvements.
• Participate in Gemba walks.
• Communicate and resolve discrepancies independently and escalate as required.
• Author, review, and approve procedural documents.
• Maintain compliance with assigned learning plan.
• Provide guidance and training for QA personnel; may own training curriculum and content.
• May present individual topics during audits as needed.
• Independently assess discrepancies for entry into quality system and approve deviations as applicable.
• May serve as quality subject matter expert for risk assessments, change controls, etc.
• Lead meetings and represent function at cross-functional meetings.
• Share data/knowledge within and across teams.
• Build and maintain strong relationships with partner functions; may prioritize and assign tasks for the team.
• Periodically observe operations on the floor and proactively identify risks and drive improvements.
• Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals.
• Function as a project manager able to influence others based on time and task commitments; organize and run meetings.
• Obtain access to, and develop as an SME for, various electronic systems utilized by Shop Floor Quality (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.).
• Familiarity with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring, and Reporting.
• Share data/knowledge within and across teams by acting as a champion for quality culture and learning.

Requirements

• Ability to research, understand, interpret, and apply internal SOPs, policies, and regulatory guidelines.
• Proficient computer skills with knowledge of digital tools such as MS Office and ability to learn and work with new software applications.
• Ability to interpret data and results, understand complex problems with multiple variables, and articulate practical solutions.
• Excellent written and verbal skills; ability to present technical data effectively based on target audience.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Detail-oriented and task-focused with the ability to meet deadlines and support work prioritization.
• Ability to negotiate and influence to craft mutually beneficial solutions.
• Ability to motivate and foster a positive team environment.
• Strong decision-making ability and creative thinking while maintaining compliance and quality.
• Pioneering mindset and ability to create innovative solutions.
• Demonstrated experience with quality management systems for handling records such as change control, product complaints, deviations, investigations, and CAPA management.
• Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.
• Bachelor's degree in a STEM field preferred. High school diploma/Associate's degree with equivalent combination of education and work experience may be considered.
• 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Demonstrated experience with quality management systems.
• Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.

Working Conditions

• Able to gown for ISO 8 rooms (medical scrubs, safety shoes, safety glasses, gloves, etc.).

Pay

Devens, MA, US: $89,780 - $108,789. The starting compensation range is for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life Benefits:
  • Paid Time Off:
    • US Exempt Employees: Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio employees).
    • Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Based on eligibility, additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year's Day.

All global employees (full and part-time) who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.