Manager, Shop Floor Quality Assurance, Cell Therapy in Devens, MA

Role Summary

This is a key role on the Shop Floor Quality Assurance team. As Manager, Shop Floor Quality Assurance, Cell Therapy, you will lead a team of 4-8 employees. The role oversees 24x7 quality collaboration and site operations quality, partnering with Manufacturing, Quality Control laboratories, and Warehouse Operations to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. The position is based in Devens, MA and reports to the Senior Manager, Field Quality Assurance for the Devens CTF. Shifts available are 6am–6pm, rotating including holidays and weekends, onsite.

Responsibilities

• Provide leadership to ensure routine on-the-floor quality oversight and collaboration in triaging unexpected events across Manufacturing, Quality Labs, and Supply Chain operational areas.
• Have a comprehensive understanding of Cell Therapy processes to enable real-time decision-making.
• Synthesize information from multiple sources, interpret problems, and communicate clearly to cross-functional management.
• Respond to complex issues and build consensus with subject-matter experts for product impact and continuing manufacturing decisions.
• Serve as a subject matter expert supporting others to navigate the quality management system (deviation and CAPA management, interim production controls, disposition decisions, and batch record management).
• Provide direction to QA shift-managers for handling and resolution of cGMP events (deviations, batch record exceptions, and other quality issues).
• Be accountable for the performance of the QA field quality organization, including oversight of QA on-the-floor systems and programs.
• Develop and implement standard-work balancing on-floor support for non-routine events, routine QA work, and development projects.
• Promote a culture of psychological and physical safety, teamwork, communication, and continuous improvement.
• Identify quality risks and critical issues, drive mitigations with Field Quality Staff and cross-functional partners, and escalate as needed.
• Lead walkthroughs with peers to identify and remediate quality issues.
• Review and interpret investigation conclusions and provide constructive feedback.
• Independently approve deviation records in the quality management system consistent with quality risk management.
• Coach and mentor operators and Field QA specialists on the manufacturing floor.
• Interview, hire, coach, motivate, and develop staff; set objectives and conduct performance reviews.

Qualifications

• Required: Ability to lead on-site quality operations teams working a 6am–6pm shift on a rotating schedule.
• Required: Demonstrated experience with quality management systems handling records such as change control, product complaints, deviations, investigations, and CAPA management.
• Preferred: Experience in aseptic/sterile environments and/or quality control operations focused on microbial controls and contamination mitigation.
• Required: Ability to research, understand, interpret, and apply internal policies and regulatory guidelines.
• Required: Proficiency with MS Office and ability to learn new software applications; strong data interpretation and problem-solving skills.
• Required: Excellent written and verbal communication; ability to present technical data to varied audiences.
• Required: Ability to work in a fast-paced team environment, lead through changing priorities, and think strategically.
• Required: Ability to negotiate and influence to craft mutually beneficial solutions; motivate teams; maintain compliance and quality.
• Required: Experience with GxP electronic systems (e.g., MES, SAP/ERP, LIMS, TrackWise/Veeva).
• Required: Ability to lead change in a fast-paced environment with limited information and/or time constraints.
• Required: Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
• Preferred: Experience with lean, six-sigma, or as a process engineer in biopharma.

Education

• Preferred: Bachelor's degree in a STEM field. Higher education or related experience may be considered in lieu of degree.

Skills

• Ability to lead on-site quality operations teams and manage rotating shift schedules.
• Strong understanding of quality management systems and regulatory requirements.
• Proven ability to interpret data, solve complex problems, and communicate solutions effectively.
• Technical writing and verbal communication excellence; ability to tailor messaging to audience.
• Capability to coach, mentor, and develop staff; strong leadership and interpersonal skills.
• Experience with manufacturing execution systems (MES), ERP (e.g., SAP), LIMS, and QMS (e.g., TrackWise or Veeva).

Additional Requirements

• PHYSICAL/MENTAL DEMANDS: Able to work near strong magnetic fields; able to gown for ISO 8 and ISO 7 rooms (scrubs, safety shoes, safety glasses, gloves).