Senior QC Investigator & Compliance Lead

Bristol Myers Squibb EU Policy; Bothell (WA); On-site; USD 120,000 - 146,000; Full time

Job summary

Bristol Myers Squibb is seeking a Subject Matter Expert to lead and author QC deviations, investigations, CAPAs and change controls. Represent the department in internal and external inspections and may support APQR sections.

The role requires advanced knowledge of regulatory requirements and strong technical writing skills, with emphasis on quality systems and continuous improvement in a fast-paced environment.

Qualifications

• Advanced knowledge of Global Regulatory and cGMP requirements.
• Strong root-cause analysis and laboratory investigation skills.
• Advanced technical writing for quality/compliance documentation.
• Experience with Quality management systems and CAPA processes.
• Experience leading regulatory inspections and responses.

Responsibilities

• Lead and author QC deviations, investigations, CAPAs and change controls.
• Conduct root cause analyses and regulatory-compliant investigations.
• Generate and report KPIs; escalate at-risk items and CAPA effectiveness.
• Manage document revisions, projects, CAPA/deviation/investigation efforts.
• Train and mentor colleagues on deviation, investigation, CAPA and change control processes.

Skills

Regulatory knowledge

Root cause analysis

Regulatory writing

Quality systems

Education

Bachelor’s degree in science

Advanced degree preferred

Job description

Bristol Myers Squibb is seeking a Subject Matter Expert to lead and author QC deviations, investigations, CAPAs and change controls. Represent the department in internal and external inspections and may support APQR sections.

The role requires advanced knowledge of regulatory requirements and strong technical writing skills, with emphasis on quality systems and continuous improvement in a fast-paced environment.