Senior Manager, Computer Systems Validation

Bristol Myers Squibb

Summit, NJ, United States
Base: $125,740 - $152,368; bonus/equity: + incenti...
50% onsite
Gmp computerized systems validation
21 cfr part 11 compliance
Iq, oq, pq, uat protocol execution
This role supports the design, development, delivery, validation, maintenance, and support of GMP computerized systems at multi-use sites

Job Summary

  • This role supports the design, development, delivery, validation, maintenance, and support of GMP computerized systems at multi-use sites.
  • Key responsibilities include managing a team, leading commissioning, qualification, and validation activities, and ensuring compliance with regulatory requirements.
  • Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with the resources to pursue their goals, both at work and in their personal lives.

Matching Summary

This role supports the design, development, delivery, validation, maintenance, and support of GMP computerized systems at multi-use sites.

Salary

Base: $125,740 - $152,368; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • GMP computerized systems validation
  • 21 CFR Part 11 compliance
  • IQ, OQ, PQ, UAT protocol execution
  • Regulatory compliance in pharma
  • System risk assessments

Nice-to-have

  • Continuous Improvement efforts
  • Excellent customer service
  • Positive team environment
  • Adaptability to new technologies

Key Requirements

  • Minimum 10 years GMP experience
  • Minimum 7 years CSV experience
  • Minimum 5 years management experience
  • Experience with regulatory audits
  • BS in Computer Engineering or related

Work Rights

Not specified

Tailored Resume

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