Cell Therapy QC Compliance Expert

Bristol Myers Squibb; Bothell (WA); Hybrid; USD 108,000 - 131,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

11 paid holidays

Paid vacation time

Job summary

Bristol Myers Squibb is seeking a subject matter expert to lead and author QC deviations, investigations, CAPAs and change control in Bothell, WA. This role supports APQR sections and partners with QC SMEs to ensure timely, compliant closures and robust documentation.

You will own document revision, drive continuous improvement, train others, and represent the department during internal and external inspections, enabling high standards of quality and patient safety.

Qualifications

• Deep understanding of Global Regulatory and cGMP requirements.
• Strong problem-solving and analytical skills.
• Excellent written and verbal communication with cross-functional teams.
• Experience leading investigations and CAPA programs.
• Familiarity with QC deviations and change control processes.

Responsibilities

• Lead and author QC deviations, investigations, CAPAs, and change control.
• Collaborate with QC SMEs for root cause analysis and timely closures.
• Generate KPI reports and monitor CAPA effectiveness.
• Own document revision and change management projects.
• Train and mentor others on deviation and CAPA processes.
• Represent department in internal/external inspections.
• Possibly author APQR sections.
• Communicate investigation findings to governance forums.

Skills

Regulatory compliance understanding

Root cause analysis

Quality management systems

Cross-functional communication

Mentoring and training

Education

Bachelor's degree in science/engineering

6+ years QC/biopharma experience

Job description

Bristol Myers Squibb is seeking a subject matter expert to lead and author QC deviations, investigations, CAPAs and change control in Bothell, WA. This role supports APQR sections and partners with QC SMEs to ensure timely, compliant closures and robust documentation.

You will own document revision, drive continuous improvement, train others, and represent the department during internal and external inspections, enabling high standards of quality and patient safety.