Associate Director, Quality Assurance – Engineering (215)

About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. 

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at  www.civicarx.org

Job Description:

The Associate Director, Quality Assurance - Engineering will join the Civica, Inc. (“Civica”) organization and the 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 and biosimilar injectable medications.  Responsibilities of the position include establishing and maintaining quality systems and compliance oversight to ensure the validation/qualification and operation of processes, facility, equipment, and computer systems meet cGMP and Civica requirements at 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. 

The role is essential to assure the Petersburg site’s validation and qualification programs 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 also include, but are not limited to, the generation, review and/or approval of policies, procedures, reports, and other records necessary to provide quality oversight of validation, qualification and ongoing verification and operational activities of facility, utilities, process, equipment, instrumentation meet or exceed Health Agency requirements.  

Essential Duties and Responsibilities:

• Provide leadership, direction, and support to the people within Quality Assurance Engineering and other departments to ensure that they are qualified to achieve a high level of competence, are motivated and carry out their duties in a safe manner.
• Establish and maintain the site’s quality system processes related to GMP compliance of the facility, equipment, computer systems and manufacturing processes  by working across functions.
• Ensure the Quality oversight and review of validation and qualification activities and documentation for the site is performed including assurance that the appropriate resources, materials, and documentation are utilised, and that work is performed in a compliant and controlled manner.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate t