At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.
This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary: Subject matter expert leading and authoring QC deviations, laboratory investigations, CAPAs and change control. Represent department in
internal/external inspections. May author responses to regulatory
requests and inspection and may support authoring of APQR sections
for QC
Duties/Responsibilities
- ✓Subject matter expert leading and authoring QC deviations, laboratory investigations, CAPAs and change controls.
- ✓Apply technical and compliance knowledge of regulatory requirements to conduct root cause analysis and laboratory investigation on non-routine complex investigation. Ensure timely and compliant closure of investigations, deviations, CAPAs and change controls.
- ✓Generate and report KPIs. Highlight and escalate at risk items. Analyze and report CAPA effectiveness.
- ✓Own document revision, projects, CAPA and deviation/ investigation, change management and/ or continuous improvement efforts.
- ✓Train and mentor others on deviation, investigation, CAPA and change control process/ procedures.
- ✓Represent department in internal/ external inspections. May author responses to regulatory requests and inspections and represent the department in governance & review boards.
- ✓May support authoring of APQR sections.
- ✓Communicate effectively with management and cross functional
teams (e.g., present investigation findings at governance forums).
- ✓Perform other tasks as assigned.
Qualifications
Specific Knowledge, Skills, Abilities
- ✓Advanced ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
- ✓Advanced problem-solving ability/mentality, critical thinking, technically adept and logical.
- ✓Advanced ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
- ✓Ability to work in a fast-paced team environment, action oriented, highly organized to meet deadlines and prioritize work from multiple complex investigations and projects.
- ✓Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.
Education/Experience/Licenses/Certifications
- ✓Bachelor’s degree in science, engineering, or related discipline. Advance degree preferred.
- ✓8+ years of experience in biopharmaceutical or QC lab operations with 2+ years of prior investigation experience required. An equivalent combination of education and experience may substitute.
- ✓Knowledge of analytical and microbiological testing preferred.
- ✓Demonstrated advanced experience with Quality management systems.
- ✓Demonstrated advanced technical writing skills.
- ✓Demonstrated advanced experience in laboratory or biomanufacturing investigations and root cause analysis techniques.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
Bothell - WA - US: $120,320 - $145,797