Expertise in deviation capa change control systems
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Bristol Myers Squibb is seeking a Sr. Director of Quality Systems & Compliance to lead quality management at their Bothell manufacturing site. The ideal candidate should possess extensive experience in the biotech or pharmaceutical industries, particularly related to quality systems and compliance with health authority regulations.
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Job Summary
This role leads the Quality Systems and Compliance teams to ensure site-level quality processes meet cGMP compliance and effectiveness standards for cell therapy products.
The position is responsible for managing health authority surveillance and pre-licensure inspections while ensuring the site remains inspection-ready at all times.
Bristol Myers Squibb offers a competitive compensation range of $235,080 to $284,867 along with comprehensive benefits including medical, dental, vision, and 401(k) plans.
Matching Summary
Match Score: 75
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Bristol Myers Squibb is seeking a Sr. Director of Quality Systems & Compliance to lead quality management at their Bothell manufacturing site. The ideal candidate should possess extensive experience in the biotech or pharmaceutical industries, particularly related to quality systems and compliance with health authority regulations.
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Salary
Base: $235,080 - $284,867; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off, and wellness programs
Skills & Requirements
Must-have
12+ years experience in Cell Therapy or Biotech
Deep knowledge of FDA EMA PMDA regulations
Expertise in Deviation CAPA Change Control systems
Experience managing Health Authority inspections
Strong background in Data Integrity programs
Proficiency with Quality Management Systems
Nice-to-have
Six Sigma Lean methodology experience
FMEA Root Cause Analysis expertise
Cross-functional collaboration skills
Innovative and proactive mindset
Advanced leadership and mentoring abilities
Key Requirements
Bachelor's degree in science discipline
12+ years of industry experience
Proven experience interfacing with health authorities