Systems Manager, Digital Quality

OXB

Durham, NC, US
On-site
Digital quality and data integrity
Gxp requirements and regulations
System development life cycle (sdlc)
Provide leadership and oversight for the quality and compliance of computerized and software systems, across all phases of the System Development Life Cycle

Job Summary

  • Provide leadership and oversight for the quality and compliance of computerized and software systems, across all phases of the System Development Life Cycle.
  • Serve as the site Subject Matter Expert, for digital quality and data integrity, ensuring adherence to GxP requirements, corporate digital governance programs, and regulatory expectations.
  • We are Looking For: Bachelor’s degree or higher in IT, Computer Systems, Life Sciences, Engineering, or a related field. Minimum of 5-7 years in the pharmaceutical/biotechnology industry, including IT compliance, digital quality, or computerized systems.

Matching Summary

Provide leadership and oversight for the quality and compliance of computerized and software systems, across all phases of the System Development Life Cycle.

Skills & Requirements

Must-have

  • Digital quality and data integrity
  • GxP requirements and regulations
  • System Development Life Cycle (SDLC)
  • Data Integrity steward
  • Inspection readiness

Nice-to-have

  • AI/ML and automation familiarity
  • Next-generation laboratory platforms

Key Requirements

  • Bachelor's degree or higher
  • 5-7 years of experience
  • Pharmaceutical/biotechnology industry experience
  • GxP-compliant computerized system programs
  • Data integrity controls experience
  • High-performance team management
  • Global GMP regulations knowledge

Work Rights

Must be eligible to work in the United States

Tailored Resume

Cover Letter