Manager Document Control and Training

Petersburg, VA
November 16, 2024

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Job Description

About Civica:

In the last 20 years, the U.S. has faced a significant rise in shortages of essential generic injectable medications, with over 300 reported shortages. This crisis stems from “race to the bottom” pricing, manufacturing challenges, and predatory pricing, ultimately impacting patients the most.

Civica, a 501(c)(4) social welfare organization founded in 2018 by various health systems and philanthropies, aims to combat these shortages and high prices. With over 55 health systems representing 1,500 hospitals, Civica also supplies essential medicines to the U.S. Department of Veterans Affairs and the Department of Defense. Their guiding principle is to “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission to include reducing pharmacy costs through its sister organization, CivicaScript, and is developing affordable biosimilar insulin to support those in need.

Job Description:

The Quality Document Control and Training Manager will oversee document control and training at Civica’s Petersburg, Virginia site, dedicated to manufacturing essential sterile injectable medications. This role ensures compliance with regulatory standards and leads the quality document control and training team.

Essential Duties:

  • Manage document control, records retention, and training activities.
  • Establish and maintain the site’s quality system framework.
  • Develop and improve quality processes.
  • Oversee document control and training management systems.
  • Analyze quality system data and present findings.
  • Identify and resolve problems collaboratively.
  • Develop personnel and promote a quality mindset.
  • Maintain training procedures and support compliance training.
  • Stay updated on FDA and Civica requirements.
  • Support regulatory inspections as needed.

Basic Qualifications:

  • 8 years in pharmaceutical or medical device industries.
  • Strong project management and organizational skills.
  • Quality system management experience.
  • 3 years in a supervisory role.
  • Excellent communication skills and software proficiency.
  • Self-motivated and adaptable in a fast-paced environment.
  • Ability to work autonomously within guidelines.
  • Committed to high-quality results and continuous learning.

Preferred Qualifications:

Experience with Veeva Quality Management Systems.