Technical Manager, QA Programs & Systems

Bristol Myers Squibb

Bothell (WA)

On-site

USD 103,000 - 125,000

Full time

3 days ago
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Benefits offered by this job

Health Coverage
Wellbeing Programs
401(k) plan
Paid Time Off

Job summary

Bristol Myers Squibb in Bothell, WA seeks a Technical Manager, QA Programs & Systems to own and coordinate the QA Shop Floor (QASF) programs, serving as program owner and POC for change controls, risk assessments, document and training lifecycle management, and operational-excellence initiatives.

You will work across Manufacturing, Quality Control, Warehouse and MSAT, translating governance decisions into shop-floor action and driving interdependent workstreams to completion with a strong

Qualifications

  • 5+ years of relevant cGMP experience, preferably in biotechnology, cell therapy, or an equivalent regulated environment.
  • Demonstrated ownership of cross-functional quality programs and systems (change control, document lifecycle, deviations/CAPA, risk assessments) and effective project management driving deliverables to completion.

Responsibilities

  • Serve as a Change Control Champion: 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.
  • Build systems and programs that improve NPI readiness across QASF teams.
  • Create, update, and manage QASF training curricula in alignment with the Learning Grid; act as POC for new-hire (FTE) learning and onboarding.
  • Represent QASF at the Contamination Control Committee (C3) as POC for aseptic process improvements; sustain the Aseptic Observer Program and drive future enhancements.
  • Lead and participate in risk assessments — driving updates, continuous improvement, and cross-functional alignment using tools such as Failure Mode and Effects Analysis (FMEA).
  • Represent QASF at Compliance Connect quarterly governance meetings.
  • Provide operational support and escalation/triage management for high-risk, high-impact events, leading escalated triage actions as needed.

Skills

cGMP experience
Project management
Cross-functional collaboration

Education

Bachelor's degree in STEM

Job description

Bristol Myers Squibb in Bothell, WA seeks a Technical Manager, QA Programs & Systems to own and coordinate the QA Shop Floor (QASF) programs, serving as program owner and POC for change controls, risk assessments, document and training lifecycle management, and operational-excellence initiatives.

You will work across Manufacturing, Quality Control, Warehouse and MSAT, translating governance decisions into shop-floor action and driving interdependent workstreams to completion with a strong

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