Manager II, QA Shop Floor

Bristol Myers SquibbBothell, WA
8dOnsite

About The Position

The Quality Assurance (QA) Manager II is a frontline people leader responsible for managing QA Shop Floor teams at the BMS Bothell, WA cell therapy facility. This role drives end-to-end quality execution, from material receipt to final product release, in an expanding, fast-paced biotech manufacturing environment. You will lead teams providing real-time quality decision-making, batch record review, and deviation management in direct partnership with Manufacturing, Quality Control, and Supply Chain. Success requires deep technical expertise in cGMP requirements, robust knowledge of Risk and Quality Management Systems, and a proven ability to lead high-performing teams in a regulated environment. This role provides critical leadership for PM shift operations - standard hours for the role are Monday through Friday, 1:00 PM to 9:30 PM.

Requirements

  • Decision-Making & Risk Management: Exercises sound judgment to evaluate complex information and drive real-time technical actions. Correlates events to identify root cause and implement robust solutions.
  • Technical Expertise: Deep understanding of cGMP requirements, aseptic processing, and data integrity principles within biopharmaceutical manufacturing or cellular therapies.
  • People Leadership: Proven ability to develop personnel and cultivate a high-accountability culture. Drives team ownership of results while maintaining rigorous attention to detail and a commitment to continuous learning.
  • Cross-Functional Influence: Skilled collaborative leader with a track record of engaging cross-functional partners (Manufacturing, QC, and Supply Chain) to drive alignment and resolve operational barriers.
  • Education: Bachelor’s degree in a STEM field (Science, Technology, Engineering, or Mathematics) or equivalent experience.
  • Experience: Minimum of 5 years in cGMP-regulated environments (pharmaceuticals, biologics, or cell/gene therapy).
  • Leadership Experience: Minimum of 2 years in a formal people leadership role with a proven track record of developing, coaching, and mentoring personnel.

Responsibilities

  • Promotes a safety-first and quality-always culture and ensures compliance with cGMPs, company policies, and procedures.
  • Identifies and mitigates quality and operational risks that could impact product safety, identity, strength, purity, or quality.
  • Supports deviation investigations, ensuring appropriate categorization, risk assessment, and timely closure of deviations, CAPAs, change controls, and process transfers.
  • Develops and manages the daily QA Shop Floor operations based on the production schedule.
  • Build strong cross-functional partnerships within Manufacturing and Quality leadership and across departments.
  • Recruits, coaches, and develops staff; sets clear objectives, conducts performance reviews, and supports career advancement and mentoring.

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.
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