Base: $187,700 - $243,368 depending on location; b...
Hybrid (50% onsite)
10+ years regulatory compliance experience
Fda ema pmda health authority inspection support
Global gxp standards knowledge
Bristol Myers Squibb is seeking a Director of Inspection Readiness to ensure organizational preparedness for regulatory inspections across its pharmaceutical and medical device operations. The ideal candidate will have extensive experience in regulatory compliance and quality assurance, along with exceptional leadership and communication skills
Job Summary
This role is responsible for driving the development and execution of a Global Quality inspection readiness strategy to ensure an always-ready state of compliance.
The position requires extensive experience supporting Health Authority inspections including roles as inspection facilitator, front-room SME, and back-room support.
Bristol Myers Squibb offers competitive benefits including medical, dental, vision care, 401(k) plans, and flexible time off options.
Matching Summary
Match Score: 85
Bristol Myers Squibb is seeking a Director of Inspection Readiness to ensure organizational preparedness for regulatory inspections across its pharmaceutical and medical device operations. The ideal candidate will have extensive experience in regulatory compliance and quality assurance, along with exceptional leadership and communication skills.
Salary
Base: $187,700 - $243,368 depending on location; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Comprehensive health coverage, 401(k), paid time off, and wellbeing programs
Skills & Requirements
Must-have
10+ years regulatory compliance experience
FDA EMA PMDA health authority inspection support
Global GxP standards knowledge
Mock inspection and gap analysis execution
Cross-functional stakeholder collaboration
Nice-to-have
Prior Health Authority inspector experience
Predictive Quality insights application
Thought leadership in inspection readiness
Enterprise-level compliance systems proficiency
Key Requirements
Bachelor's degree in Natural Science or Pharmacy
10+ years progressive experience in QA/QC and regulatory compliance
Experience leading internal audits of manufacturing sites
In-depth knowledge of FDA, EMA, PMDA, NMPA regulations