QA Programs & Systems Architect

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

Job summary

Bristol Myers Squibb in Bothell, WA is seeking a Technical Manager for QA Programs & Systems to own and coordinate QA Shop Floor programs across manufacturing and QC. You will drive change controls, NPI readiness, training lifecycle management, and aseptic improvements, working with cross-functional teams to ensure inspection readiness.

The role emphasizes project management, systems thinking, and execution to connect governance decisions with shop-floor action, reporting to Quality Operations.

Qualifications

• Bachelor's degree in a STEM field preferred; other Bachelor's degrees with an equivalent combination of education and experience will be considered.
• 5+ years of relevant cGMP experience, preferably in biotechnology, cell therapy, or an equivalent regulated environment.
• Ownership of cross-functional quality programs and systems (change control, document lifecycle, deviations/CAPA, risk assessments) with effective project management to drive deliverables.

Responsibilities

• Author and lead change controls, promote best practices, and represent QASF at the CC Community of Practice (COP).
• Coordinate QASF NPI operational support, managing interdependencies across protocols and execution.
• Create, update, and manage QASF training curricula in alignment with the Learning Grid; act as POC for new-hire learning and onboarding.
• Represent QASF at the Contamination Control Committee (C3) as POC for aseptic process improvements; sustain the Aseptic Observer Program.
• Lead and participate in risk assessments — driving updates, continuous improvement, and cross-functional alignment using FMEA.
• Represent QASF at Compliance Connect quarterly governance meetings to strengthen inspection readiness and site improvements.
• Provide operational support and escalation/triage management for high-risk events.

Skills

Project management

Quality systems

Change control

Risk assessment

Cross-functional collaboration

Education

Bachelor's degree in STEM field

Job description

Bristol Myers Squibb in Bothell, WA is seeking a Technical Manager for QA Programs & Systems to own and coordinate QA Shop Floor programs across manufacturing and QC. You will drive change controls, NPI readiness, training lifecycle management, and aseptic improvements, working with cross-functional teams to ensure inspection readiness.

The role emphasizes project management, systems thinking, and execution to connect governance decisions with shop-floor action, reporting to Quality Operations.