QA Programs Lead: Shop Floor Excellence

Biopharma Careers; Bothell (WA); On-site; USD 103,000 - 125,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support programs

401(k) plan

Paid Time Off

Job summary

Bristol Myers Squibb Bothell site seeks a Technical Manager, QA Programs & Systems. This role owns QA Shop Floor (QASF) programs and serves as program owner, project manager, and POC for QA Operations related change controls, risk assessments, document and training lifecycle management, ensuring inspection readiness.

Working horizontally across Manufacturing, Quality Control, Warehouse, and MSAT, the role translates governance decisions into shop-floor action and drives interdependent

Qualifications

• 5+ years of cGMP experience in biotechnology, cell therapy, or similar regulated environments.

Responsibilities

• Lead and own Change Controls, authoring and guiding execution.
• Coordinate QASF NPI operational support and readiness across protocols.
• Create and manage QA training curricula and onboarding for new hires.
• Represent QASF at the Contamination Control Committee and drive aseptic improvements.
• Lead risk assessments (e.g., FMEA) and drive continuous improvement across programs.
• Support Compliance Connect governance and maintain inspection readiness.
• Provide escalation/triage for high-risk, high-impact events.

Skills

Change Control

Project management

Quality systems

Risk assessments

Cross-functional collaboration

Education

Bachelor's degree in STEM

Tools

FMEA

Job description

Bristol Myers Squibb Bothell site seeks a Technical Manager, QA Programs & Systems. This role owns QA Shop Floor (QASF) programs and serves as program owner, project manager, and POC for QA Operations related change controls, risk assessments, document and training lifecycle management, ensuring inspection readiness.

Working horizontally across Manufacturing, Quality Control, Warehouse, and MSAT, the role translates governance decisions into shop-floor action and drives interdependent