Technical Manager - QA Programs & Systems
Bristol-Myers Squibb
- Location
- Bothell - WA - US
- Work model
- On-Site
- Level
- Senior
- H-1B history
- 57 approvals (FY2023)
- Posted
- 3h ago
About this role
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
Position
Summary The Technical Manager, QA Programs & Systems owns and coordinates the QA Shop Floor (QASF) programs that enable frontline QASF operational success at the BMS Bothell cell therapy site. This individual-contributor role serves as program owner, project manager, and subject-matter POC for QA Operations related change controls, risk assessments, document and training lifecycle management, and operational-excellence programs — keeping each on schedule, inspection-ready, and connected to its dependent systems. Working horizontally across Manufacturing, Quality Control, Warehouse, and MSAT, the role translates governance decisions into shop-floor action and represents QASF in site and global forums. Success depends on project management, systems thinking, and a high degree of execution and ownership to drive interdependent workstreams to completion through influence.
Key Responsibilities
Change Controls Serve as a Change Control Champion: author and lead change controls, promote best practices, and represent QASF at the CC Community of Practice (COP). Project-manage Change Control Impact Assessments (CC IAs) for site and global changes — coordinating stakeholders, mapping dependencies, and driving to completion. New Product Introduction (NPI) Coordinate QASF NPI operational support, managing interdependencies across protocols and execution. Build systems and programs that improve NPI readiness across QASF teams. Training Lifecycle Management Create, update, and manage QASF training curricula in alignment with the Learning Grid; act as POC for new-hire (FTE) learning and onboarding. Sterility Assurance Represent QASF at the Contamination Control Committee (C3) as POC for aseptic process improvements; sustain the Aseptic Observer Program and drive future enhancements. Risk Management Lead and participate in risk assessments — driving updates, continuous improvement, and cross-functional alignment using tools such as Failure Mode and Effects Analysis (FMEA). Compliance Initiatives Represent QASF at Compliance Connect quarterly governance meetings. Strengthen facility inspection readiness: complete Guest Auditor certification and lead facility improvements through continuous oversight reinforce a state of continuous readiness. Escalations Provide operational support and escalation/triage management for high-risk, high-impact events, leading escalated triage actions as needed. Reporting Relationship This role reports to the Associate Director, Quality Operations. This is a technical individual-contributor role with no direct reports.
Qualifications
Education: Bachelor's degree in a STEM field preferred; other Bachelor's degrees with an equivalent combination of education and experience will be considered.
Experience
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