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. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third 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 recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.
Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.
The Quality Systems Associate will join the Civica, Inc. (“Civica organization and its newly forming team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica's new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.
The role is essential to assure the Petersburg site's manufacturing and operations activities comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines.
Responsibilities of the position include establishing and maintaining quality and compliance processes associated with sterile manufacturing and operations from the onset of building and qualifying the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
Responsibilities include but are not limited to supplier and material qualification, audits, and inspections. The Quality Systems Associate will assist in developing processes and procedures in support of the Quality Management system consistent with Food and Drug Administration (FDA) regulations and current good manufacturing practices (CGMPs).
Essential Duties and Responsibilities:
Working across functions to support the establishment and maintenance of the site's quality systems and processes necessary to enable the development and reliable supply of Civica generic medications to patients
Support the development and/or improve quality processes and systems across the product lifecycle including supplier and material qualifications, internal self-inspections, and regulatory inspections
Ensure quality agreements are established for GMP suppliers and service providers
Monitor and conduct self-inspections/audits on the shop floor
Review and approve GMP documentation
Support CGMP compliance and inspection readiness within organization
Ensure that procedures are being followed as outlined under FDA, DEA, ISO, USP and CGMP guidelines
Track, trend, and analyze quality system data and information for the site
Participate and/or lead various Quality Systems processes including change controls, investigations, and corrective and preventative action (CAPA) plans
Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions
Practice and promote a safety and quality mindset and quality excellence approach to all activities
Basic Qualifications and Capabilities:
Bachelor's degree in a scientific discipline with a minimum of 3 years Quality/CGMP experience in the pharmaceutical industry.
Excellent written/oral communication skills with a strong discipline in Microsoft Programs is required.
Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
Ability to work autonomously within established guidelines, procedures, and practices.
Committed to delivering high quality results, overcoming challenges, and focusing on what matters.
Continuously looking for opportunities to learn, build skills and share learning.
Experience in the manufacture of sterile injectable pharmaceutical products is preferred