Manager, Quality Assurance Shop Floor, Cell Therapy

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Quality Assurance Shop Floor (QASF) organization has responsibility for quality oversight and responsibility for advising and assuring quality operations at the Devens Cell Therapy Facility in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs).

In the capacity of QA Shop Floor Support, the Manager, Shop Floor QA, Cell Therapy shall be responsible for handling Quality Assurance Shop Floor internal compliance and documentation tasks, routine communication to front line employees, and metrics/monitoring for key QASF processes. The incumbent will be considered a local process owner for core QASF systems/processes including but not limited to Alarm Review, Batch Record Review, and the GMP Walkthrough Program. The incumbent will be the steward for standard operating procedures, training, and managing relationships with key stakeholders.

They will be accountable to monitor and track process performance related to key Shop Floor quality assurance quality tasks and other operational tasks through data and analytics; to own, review or approve Floor Quality GxP records including but not limited to procedures, CAPAs, change controls, impact assessments, documentation, or deviations; and represent QASF at relevant governance forums. Additionally, the incumbent shall flex to support ad-hoc deviation approval or batch record review as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed.

This position reports to the Associate Director, Shop Floor Quality Assurance.

This is an individual contributor role working Monday to Friday.

Shifts Available:

M - F, Standard Working Hours

Responsibilities:

• Accountable for the performance/delivery of the QASF quality organization, including oversight of the “QA on-the-floor” systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks.
• Develop and implement, and continuously improve standard procedures and training for team-members related to quality systems.
• Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Quality Assurance staff and cross-functional partners and escalate to senior management as needed.
• Lead and/or represent QA in leadership, staff and tier meetings, governance forums or on project teams.
• Act as a QASF subject matter expert on behalf of the facility during audits and inspections.
• Provide timely QASF support to site compliance activities such as Change Control impact assessments, deviation impact assessments, and development of corresponding CAPAs.
• Advanced ability to synthesis information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner.
• Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to continue manufacturing.
• Serve as a subject matter expert supporting others to navigate the BMS quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record management. 
• Provide leadership to ensure routine on-the-floor Quality oversight and to ensure collaborative triages of unexpected events within the Manufacturing, Quality Labs, and Supply Chain operational areas and systems.
• Have a comprehensive understanding of Cell Therapy processes to enable real-time decision-making.
• Champion a culture that embraces psychological and physical safety of employees in the work environment.
• Champion a culture of teamwork, communication, and continuous improvement focused on defining problem statements, driving initial investigative efforts, and actioning solutions to reduce recurrence.
• Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
• Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge.
• Spend time coaching and mentoring operators and QASF staff while on the manufacturing floor.

Knowledge and Skills:

• Ability to research, understand, interpret, and apply internal policies and regulatory guidelines.
• Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications.
• Advanced ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
• Excellent written and verbal skills and advanced 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.
• Ability to think strategically, 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
• Exhibit strong decision-making and ability to think creatively while maintaining compliance and quality
• Pioneering mindset and ability to create innovative solutions.
• Demonstrated experience working with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or Quality Management Systems such as TrackWise or Veeva.
• Experience with microbial controls, lean or six-sigma improvements, or as a technical/scientific process engineer in the biopharmaceutical industry preferred.
• Demonstrated experience with quality management systems.
• Demonstrated experience with electronic system and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP)

Basic Requirements:

• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 6+ years of relevant cGMP experience, preferably with 2+ year of QA shop floor experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Project management experience is preferred.

Working Conditions:

PHYSICAL /MENTAL DEMANDS: 

• Able to work near strong magnetic fields.
• Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, etc.).

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