Manager I - QA Shop Floor

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.

Summary

The QA Shop Floor (QASF) Manager is a frontline quality operations people leader accountable for the coordination, execution, and continuous improvement of day-to-day QA operations in support of clinical and commercial cell therapy manufacturing. This role is central to maintaining shift readiness, delivering real-time quality oversight, and ensuring the timely identification and resolution of quality events — all while cultivating a strong culture of cGMP compliance and operational excellence.

As a key escalation point for quality decisions, the QASF Manager owns critical GMP documentation and deviation management processes, and drives cross-functional alignment through structured, proactive communication. The role carries direct accountability for team performance and deliverables, while actively mentoring QA personnel and contributing to broader site quality strategy and team culture.

Scheduled Hours

Sunday – Wednesday | 13:30 – 00:00

Roles and Responsibilities

• Frontline Quality Oversight - Ensure and lead operational walkthroughs with cross-functional teams to assess and reinforce real-time cGMP compliance. Serve as the on-shift quality, proactively identifying and resolving compliance risks.

• Escalation Management & Shift Leadership - Act as the primary QA decision-maker for shift-level escalations, applying risk-based judgment to quality issues as they arise. Ensure effective resource deployment across batch record review, document approval, deviation triage, and shop floor coverage — maintaining clear communication with stakeholders and QA peers throughout.

• Deviation Management - Drive management of quality exception events using a structured, risk-based approach aligned to site SOPs. Ensure timely scoping, immediate containment actions, and appropriate escalation to minimize impact to product quality, patient safety, process integrity, and business continuity. Partner cross-functionally to drive deviation resolution and CAPA closure.

• GMP Document Lifecycle Ownership - Serve as lifecycle owner for critical GMP documentation including batch records, SOPs, and controlled quality documents. Manage revision timelines, change dependencies, and periodic review cycles — championing right-first-time documentation quality across the team.

• Cross-Functional Quality Leadership - Represent QA in technology transfers, process changes, and new product introductions, ensuring quality principles are embedded from planning through execution. Contribute to protocols, risk assessments, and site initiatives while modeling a culture of accountability, transparency, and patient-first thinking.

 This role reports to Associate Director – QA Operations

Education

• Bachelor's degree in a STEM (Science, Technology, Engineering and Math education) field is preferred

• Associates degree with equivalent combination of education and work experience may be considered.

Experience

• 4+ years of relevant cGMP experience in regulated environments such as pharmaceuticals, biotechnology, or cell therapy manufacturing.

  Previous people leadership experience is preferred.

• Strong demonstrated expertise in manufacturing systems such as MES, ERP (SAP), Deviation Management and eDMS systems.

• Proven