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Quality Systems Manager, Pharmaceutical

Company: Civica
Location: Petersburg
Posted on: January 16, 2022

Job Description:

About CivicaOver the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration's shortage list. Manufacturing challenges and predatory pricing are both the cause and result. Who suffers most? Patients. Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Led by an experienced team of health care and pharmaceutical industry leaders. Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Civica is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been Do What Is in the Best Interest of Patients. Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs. To find out more about how Civica's innovative model is directly impacting patient care, to read a recent article from the New England Journal of Medicine. Intro to Civica Essential Duties and Responsibilities:

  • Working across functions, lead the establishment and maintenance of the site's quality system framework including quality systems and processes necessary to enable the development and reliable supply of Civica generic medications to patients.
  • Develop and/or improve quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
  • Track, trend, and analyze quality system data and information for the site including, but not limited to change controls, corrective and preventive actions, audit findings, deviations, complaint information, notifications to management, and health authority communications and notifications. Recommend action and continuous improvement plans. Summarize findings and recommendations for management and team awareness and/or present at routine Quality Council meetings.
  • Participate or lead the assessment, qualification, and approval of suppliers.
  • Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
  • Promote a quality mindset and quality excellence approach to all activities.
  • Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
  • Travel (up to 10%) may be required.
    Basic Qualifications and Capabilities:

    • Bachelor's degree in a scientific discipline with a minimum of 8 years Quality/CGMP management experience in the pharmaceutical industry.
    • Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
    • Quality system management experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
    • Participation and leading activities to support regulatory agency inspections required.
    • Minimum of 2 years experience in a supervisory role highly desired.
    • Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
    • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
    • Ability to work autonomously and within established guidelines, procedures, and practices.
    • Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
    • Continuously looking for opportunities to learn, build skills and share knowledge with others.

      Preferred Qualifications:

      • Technical expertise in pharmaceutical and combination product, process, and/or method development and validation.
      • Experience in sterile injectable isolator technology, facility qualification and combination products.

        Salary DOE. Excellent benefits.

Keywords: Civica, Richmond , Quality Systems Manager, Pharmaceutical, Executive , Petersburg, Virginia

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