QA Operations Leader, Deviations & CAPA (Cell Therapy)

Bristol-Myers Squibb; Bothell (WA); On-site; USD 133,660 - 161,968; Full time

Benefits offered by this job

Health coverage

401(k) plan

Career development programs

Job summary

Bristol Myers Squibb is seeking a Sr. Manager - QA Ops, Investigations in Bothell, WA to lead a team overseeing deviation management and CAPA workflows in cell therapy manufacturing. You will ensure regulatory compliance and drive continuous improvement across site QA operations.

The role requires a strong GxP background, 3+ years of leadership, and deep knowledge of FDA/EMA regulations, RCA methods, and risk management to support site initiatives and cross-functional collaboration.

Qualifications

• Bachelor's degree in a relevant scientific or engineering discipline.
• Minimum 6 years of progressive GxP experience in biotechnology or pharmaceutical manufacturing.
• Minimum 3 years of hands-on experience managing deviation and CAPA records within quality systems.
• Minimum 3 years of leadership experience, including direct supervision and development of team members.
• Solid knowledge of FDA and EMA regulations governing pharmaceutical and biotechnology operations.
• Proficiency in advanced Root Cause Analysis (RCA) tools and methodologies.
• Experience applying Quality Risk Management principles to support robust decision-making.

Responsibilities

• Oversee and mentor a team responsible for the review, investigation, and approval of Deviations and CAPA records.
• Champion quality by leading trend investigations and driving continuous improvement initiatives.
• Provide leadership support for initiatives including Right First Time, Trending Program, and Deviation Reduction workstreams.
• Support hiring and development, onboarding and training for new hires, and foster accountability.
• Liaise with the broader BMS Network to harmonize practices and serve as Local Process Owner for Deviations.
• Collaborate with cross-functional teams to ensure robust impact assessments and timely CAPA actions.
• Engage with QA Shop Floor to advance quality maturity and regulatory compliance.

Skills

GxP experience

Deviation management

CAPA

Leadership

Root Cause Analysis

Quality Systems

Regulatory knowledge

Biotech/Cell therapy experience

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Job description

Bristol Myers Squibb is seeking a Sr. Manager - QA Ops, Investigations in Bothell, WA to lead a team overseeing deviation management and CAPA workflows in cell therapy manufacturing. You will ensure regulatory compliance and drive continuous improvement across site QA operations.

The role requires a strong GxP background, 3+ years of leadership, and deep knowledge of FDA/EMA regulations, RCA methods, and risk management to support site initiatives and cross-functional collaboration.