Technical Manager - QA Programs & Systems
About The Position
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.
Requirements
- 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.
- 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).
- Project-manage Change Control Impact Assessments (CC IAs) for site and global changes — coordinating stakeholders, mapping dependencies, and driving to completion.
- 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.
- Strengthen facility inspection readiness: complete Guest Auditor certification and lead facility improvements through continuous oversight reinforce a state of continuous readiness.
- Provide operational support and escalation/triage management for high-risk, high-impact events, leading escalated triage actions as needed.
Benefits
- Medical, pharmacy, dental, and vision care.
- BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Flexible time off (unlimited, with manager approval)
- 11 paid national holidays
- 160 hours annual paid vacation for new hires with manager approval
- 11 national holidays, and 3 optional holidays
- Unlimited paid sick time
- up to 2 paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- an annual Global Shutdown between Christmas and New Years Day.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
