Sr. Manager - Global Quality Gxp Data Integrity Sme

Bristol Myers Squibb

Devens, MA, US
Base: $142,040 - $189,324 depending on location; b...
**
Gxp data integrity expertise
Computer system validation csv
21 cfr part 11 compliance
** Bristol Myers Squibb is seeking a Sr. Manager for Global Quality GxP Data Integrity SME to oversee data integrity governance within its Global Quality organization. The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in data integrity and GxP compliance, and will play a crucial role in ensuring regulatory adherence and program success. **

Job Summary

  • This role provides subject matter expertise to establish and maintain an end-to-end Data Integrity Governance program across Bristol Myers Squibb's global sites.
  • The position is accountable for supporting regulatory agency inspections, managing remediation efforts using QRM principles, and developing data integrity policies.
  • Employees benefit from a wide variety of competitive benefits including health coverage, financial protection plans, and flexible work-life balance programs.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a Sr. Manager for Global Quality GxP Data Integrity SME to oversee data integrity governance within its Global Quality organization. The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in data integrity and GxP compliance, and will play a crucial role in ensuring regulatory adherence and program success. **

Salary

Base: $142,040 - $189,324 depending on location; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Comprehensive health, 401(k), paid time off, and wellbeing support

Skills & Requirements

Must-have

  • GxP Data Integrity expertise
  • Computer System Validation CSV
  • 21 CFR Part 11 compliance
  • Regulatory inspection support
  • Risk-based remediation management

Nice-to-have

  • Advanced analytics and AI tools
  • Digital Quality and Governance
  • Cross-functional collaboration skills
  • Data-driven insights generation

Key Requirements

  • Minimum 6 years pharmaceutical industry experience
  • Minimum 4 years Data Integrity knowledge
  • Minimum 3 years GxP CSV and Part 11 experience
  • University degree with Life-Sciences preferred

Work Rights

Not specified

Tailored Resume

Cover Letter