Senior Manager, Quality Assurance Shop Floor 2nd Shift

Position Summary

The Senior Manager, Quality Assurance Shop Floor (QASF) 2nd Shift is a key people‑leader responsible for ensuring the highest quality standards in our cGMP Cell Therapy processes at the Devens Cell Therapy Facility. The role manages night‑shift managers and their teams, drives quality excellence, and represents the night shift in cross‑functional discussions.

• Lead and mentor night‑shift managers and their teams to maintain effective communication and quality performance.
• Uphold and improve quality standards, collaborating cross‑functionally and influencing quality processes.
• Implement continuous‑improvement initiatives to enhance quality and compliance effectiveness.
• Provide leadership to ensure routine on‑floor quality oversight and triage unexpected events within Manufacturing, Quality Labs, and Supply Chain.
• Serve as subject‑matter expert for the BMS quality management system: deviations, CAPAs, interim production controls, disposition decisions, and batch record management.
• Guide QA shift managers on handling cGMP events, deviations, batch record exceptions, and other quality operational issues.
• Own performance and delivery of the QA field quality organization, including the “QA on‑the‑floor” systems and programs.
• Develop and implement standard work balancing support for non‑routine events, routine QA work, and development projects.
• Champion a culture of psychological and physical safety, teamwork, communication, and continuous improvement.
• Proactively identify and address quality risks and critical issues, driving mitigations and escalating to senior management as needed.
• Represent QA in leadership and governance meetings, audits, inspections, and stakeholder forums.
• Support site compliance activities such as change control impact assessments, deviation impact assessments, and CAPA development.
• Lead walk‑throughs with peers or QA team members to remediate operational or quality issues.
• Perform technical reviews and provide constructive feedback on records and investigations.
• Approve deviation records within the quality management system in accordance with risk‑based principles.
• Coaching and mentoring operators and field QA specialists on the manufacturing floor.
• Recruit, interview, hire, coach, motivate, and develop staff; set performance objectives, conduct performance reviews, and monitor progress.

• 8+ years of relevant cGMP experience, including 4+ years of manufacturing site experience.
• Experience leading on‑site quality operations teams on 12‑hour rotations (2‑3‑2 Panama schedule).
• Proficiency with quality management systems (change control, CAPA, deviation, complaint management).
• Knowledge of aseptic/sterile environments and quality control for microbial controls and contamination mitigation.
• Strong strategic thinking, prioritization, and enterprise‑mindset to meet business needs within budget.
• Exceptional decision‑making and analytical skills, with a focus on compliance and quality risk management.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing (required).
• Preferred:
  Experience with microbial controls, Lean or Six‑Sigma, or engineering roles in biopharma.
• Expertise in GxP electronic systems: MES, ERP (SAP), LIMS, or QMS such as Track Wise or Veeva.
• Demonstrated ability to influence cross‑functional partners, negotiate solutions, and resolve stakeholder conflicts.
• Proven skill in coaching, mentoring, and developing diverse teams.
• Master’s degree in STEM or MBA preferred; bachelor/associate degree with equivalent experience accepted.
• Ability to work within pharmaceutical cleanroom environments and near strong magnetic fields.

Night‑shift schedule: 6:00PM–6:00AM, 7days a week (Panama 3‑2‑2 rotation). On‑site at Devens, MA. Requires gowning for ISO8/ISO7 rooms and compliance with cleanroom protocols.

Devens, MA – U.S.: $130,020–$157,559 per year, with additional incentive cash and stock opportunities based on eligibility.

BMS is an equal‑opportunity employer. We consider applicants with arrest and conviction records under applicable laws. For more information, visit