QA Programs & Systems Lead: Change, NPI & Compliance

Bristol-Myers Squibb; Bothell (WA); On-site; USD 103,000 - 125,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) plan

Paid time off

Job summary

Bristol Myers Squibb seeks a Technical Manager, QA Programs & Systems for its Bothell, WA cell therapy site. The role coordinates QA Shop Floor programs, drives change controls, risk assessments, and lifecycle management to keep operations inspection-ready.

You will work across Manufacturing, Quality Control, Warehouse, and MSAT to translate governance into shop-floor action. Ideal candidates have 5+ years in cGMP, strong project management, and a track record in QA program ownership and

Qualifications

• Bachelor’s degree in STEM; equivalent experience considered.
• 5+ years of relevant cGMP experience in biotech or regulated environments.
• Proven ownership of cross-functional quality programs and project delivery.

Responsibilities

• Lead Change Controls and represent QASF in COP.
• Coordinate CC IAs across site and global teams.
• Support NPI readiness and interdependencies across protocols.
• Create and manage QA training curricula for new hires.
• Represent QA Shop Floor in aseptic/sterility improvements.
• Lead risk assessments and drive continuous improvement.
• Support compliance initiatives and readiness for inspections.
• Provide escalation/triage for high-risk events.

Skills

Project management

Quality systems

Change control

Cross-functional collaboration

cGMP compliance

Risk assessments

Education

BSc in STEM

Tools

FMEA

Document management systems

Job description

Bristol Myers Squibb seeks a Technical Manager, QA Programs & Systems for its Bothell, WA cell therapy site. The role coordinates QA Shop Floor programs, drives change controls, risk assessments, and lifecycle management to keep operations inspection-ready.

You will work across Manufacturing, Quality Control, Warehouse, and MSAT to translate governance into shop-floor action. Ideal candidates have 5+ years in cGMP, strong project management, and a track record in QA program ownership and