Senior Manager, Computer Systems Validation

Bristor Myers Squibb

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

Job Summary

  • This role supports the design, development, delivery, validation, maintenance, and support of GMP computerized systems at multi-use sites, ensuring regulatory compliance.
  • Key responsibilities include managing a team of up to 9 people, allocating resources for CSV activities, and providing technical input for validation deviations and change requests.
  • 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, ensuring regulatory compliance.

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
  • 21 CFR Part 11
  • system risk assessments
  • validation deviations
  • technical assessments
  • IQ, OQ, PQ, UAT protocols

Nice-to-have

  • customer service and support
  • continuous improvement
  • positive team environment
  • latest industry regulations

Key Requirements

  • Minimum 10 years' experience in a GMP environment
  • Minimum 7 years' experience in pharmaceutical computer systems validation
  • Minimum 5 years' experience managing personnel and/or projects
  • Experience interacting with regulatory agents and auditors
  • BS in Computer Engineering, Computer Science, or related discipline

Work Rights

Not specified

Tailored Resume

Cover Letter