Senior QA Ops Leader: Deviations & CAPA

Biopharma Careers; Bothell (WA); On-site; USD 134,000 - 162,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) Plan

Paid Time Off

Job summary

Bristol Myers Squibb in Bothell, WA is seeking a Sr. Manager of Quality Operations (Investigations) to lead deviation and CAPA workflows in cell therapy manufacturing. This role supervises a team, drives continuous improvement, and partners across QA Ops to ensure regulatory excellence.

The ideal candidate has 6+ years GxP Biopharma experience, strong RCA/QRM skills, and 3+ years of leadership. Excellent knowledge of FDA/EMA rules and a focus on Right First Time is required for success.

Qualifications

• 6+ years of progressive GxP experience in biotech/pharmaceutical manufacturing, with focus on biologics or cell therapy.
• 3+ years of hands-on experience managing deviation and CAPA records within quality systems.
• 3+ years of leadership experience, including direct supervision and development of team members.
• Solid knowledge of FDA and EMA regulations governing pharmaceutical/biotech operations.
• Proficiency in RCA tools and methodologies; experience applying QRM principles.

Responsibilities

• Oversee and mentor a team responsible for review, investigation, and approval of Deviations and CAPA records.
• Lead trend investigations and continuous improvement initiatives in Deviation and CAPA management.
• Support site initiatives like Right First Time, Trending Program, and IHHAs coordination.
• Ensure onboarding and training for new hires; foster accountability and high-quality performance.
• Collaborate with cross-functional teams to implement robust CAPA actions and risk mitigation.
• Maintain leadership presence to uphold regulatory compliance across QA Ops.

Skills

Leadership

Deviation & CAPA management

GxP experience

Root Cause Analysis (RCA)

Quality Risk Management (QRM)

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Job description

Bristol Myers Squibb in Bothell, WA is seeking a Sr. Manager of Quality Operations (Investigations) to lead deviation and CAPA workflows in cell therapy manufacturing. This role supervises a team, drives continuous improvement, and partners across QA Ops to ensure regulatory excellence.

The ideal candidate has 6+ years GxP Biopharma experience, strong RCA/QRM skills, and 3+ years of leadership. Excellent knowledge of FDA/EMA rules and a focus on Right First Time is required for success.