Quality Assurance Manager-GXP Computer Systems

Petersburg, VA
November 16, 2024

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Job Description

About Civica

Civica, a 501(c)(4) social welfare organization founded in 2018, aims to alleviate chronic generic drug shortages and high prices in the U.S. health system. Led by seasoned healthcare and pharmaceutical professionals, Civica has garnered support from over 55 health systems, encompassing more than 1,500 hospitals and one-third of U.S. hospital beds. The organization supplies essential medicines to the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile.

Recently, Civica announced CivicaScript, a new initiative to manufacture affordable insulins for diabetes patients, set to launch in 2024. This effort will provide significant cost relief for uninsured and underinsured individuals. Civica’s mission is to ensure accessible, quality generic medications for all, guided by the principle of prioritizing patient interests. Their Petersburg, Virginia facility is under construction to support this mission.

For more on Civica’s impact on patient care, read the New England Journal of Medicine summary here. To learn about their plans for affordable insulin, check out the article in BioSpace here.

Position Summary

The Quality Assurance (QA) Manager – GXP Computer Systems will join Civica to enhance the quality and compliance of essential medicines. This subject matter expert will oversee Computerized System Validation (CSV) for GXP systems, including Veeva Vault and others, ensuring adherence to regulatory standards like 21 CFR Part 11 and GAMP5. The role involves collaboration with various teams and managing change across the organization.

Essential Duties and Responsibilities

  • Lead QA for GXP computer systems, ensuring compliance with regulations.
  • Support readiness of CSV programs for audits and inspections.
  • Review GXP-related change controls and validation documentation.
  • Assess data integrity and compliance of systems.
  • Participate in vendor audits related to GXP systems.
  • Guide development of GXP procedures.
  • Collaborate on GXP compliance projects.
  • Manage quality processes in Veeva.
  • Provide ongoing support to system owners.
  • Effectively manage multiple projects and communicate across levels.

Minimum Qualifications

  • Bachelor’s in a scientific discipline, Computer Science, or IT; Master’s preferred.
  • 8+ years of experience in the pharmaceutical/biotech industry.
  • Expertise in GXP requirements and validation for SaaS systems.
  • Strong business and technology skills.
  • Proficient in Microsoft Office.
  • Excellent communication skills.
  • Ability to follow complex instructions.
  • People-oriented and collaborative.
  • Analytical thinker with problem-solving skills.
  • Strong planning and time management abilities.
  • Remote role with occasional travel (<10%).