Manager I - QA Shop Floor

Bristol Myers Squibb • Bothell, WA

2d • Onsite

About The Position

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.

Requirements

• 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
• 4+ years of relevant cGMP experience in regulated environments such as pharmaceuticals, biotechnology, or cell therapy manufacturing.
• Strong demonstrated expertise in manufacturing systems such as MES, ERP (SAP), Deviation Management and eDMS systems.
• Proven track record of making quality decisions based on risk impact to patient, product, and process; escalates and drives resolution of complex quality events

Nice To Haves

• Previous people leadership experience is preferred.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

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 include: 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 for employees 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 Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees