Lead - QA Shop Floor

Bristol Myers Squibb • Bothell, WA

8d • $44 - $54 • Onsite

About The Position

QA Shop Floor Lead is a frontline quality operations Lead responsible for coordinating and executing day-to-day QA operations to support clinical and commercial cell therapy manufacturing. This role ensures shift readiness, real-time oversight, and timely resolution of quality events while fostering a culture of cGMP compliance and operational excellence. The Lead serves as a key point of contact for internal escalations, owns critical documentation and deviation processes, and drives cross-functional alignment through proactive communication. In addition to mentoring QA team members, the Lead contributes to strategic initiatives and provides leadership continuity during manager absences and positively influences team culture as well as personal accountability for team deliverables. Note : The routine working schedule for this position is Monday - Friday, 10:00PM - 06:30AM. The position will report directly to Associate Director, QA Operations.

Requirements

• Bachelor's degree in STEM (Science, Technology, Engineering and Math education) field preferred. Associates degree with equivalent combination of education and work experience may be considered.
• 5+ years of relevant cGMP experience in regulated environments such as pharmaceuticals, biotechnology, or cell therapy manufacturing is preferred
• Demonstrated expertise in batch record review, deviation assessment, product disposition, and shop floor oversight.
• Strong demonstrated expertise in manufacturing systems such as MES, ERP (SAP), Deviation Management (Infinity) and Document Management System (BMSDocs).
• Proven track record of making quality decisions based on risk impact to patient, product, and process; escalates and drives resolution of complex quality events.
• Strong collaboration, communication, and leadership skills to influence cross-functional teams and ensure alignment with quality strategy and operational priorities.

Responsibilities

• Shift Readiness & Alignment: Coordinate daily shift readiness by prioritization of records and removing barriers to allow on time completion by collaborating with MFG/PL stakeholders and implementing improvements in TAT.
• Escalation & Communication Management: Act as the QA point-of-contact for internal escalations. Set daily QA priorities, ensure effective staffing across QA functions (triage, reviews, floor coverage), and maintain timely communication across Teams, email, and cross-functional channels.
• Shop Floor Oversight: Coordinates and schedules walkthroughs with cross-functional gemba and influencing purposeful presence on the Quality shop floor.
• Document Lifecycle Ownership: Serve as the lifecycle owner for critical GMP documents. Drive cross-functional collaboration, ensure timely updates, manage dependencies, and maintain compliance through periodic review cycles.
• Deviation Management: Lead triage and assessment of moderate-to-high impact deviations using a structured, risk-based approach. Drive timely investigation closure with accurate and appropriate documentation and coordinating completions intra- and inter- shift. with minimal leadership input.
• Cross-Functional Quality Leadership: Represent QA during planning and execution of documents, protocols, and risk assessments related to technology transfers, process changes, or new product introductions. Ensure quality principles are integrated from planning through execution.
• Managerial Absence Support: Provide leadership coverage in the absence of the QA Manager. Guide team operations, make informed decisions, lead operational handoffs, and maintain business continuity across QA Shop Floor functions

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. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level