Quality Assurance Manager

Quality Assurance Manager

Bio Space

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.

The Quality Assurance Manager will join the Civica, Inc. (“Civica”) team in supplying essential generic quality medicines to our hospital members in the United States by bringing their knowledge and experience to serve patients and pursue excellence in quality and compliance.

The Quality Assurance Manager will provide quality oversight within the Quality System, including but not limited to review of SOPs, protocols, reports, data and records generated to support the disposition and distribution of pharmaceutical product to meet business and operational requirements. The Quality Assurance Manager will develop processes and procedures in support of the Quality Management system consistent with Food and Drug Administration (FDA) regulations and current good manufacturing practices (CGMPs).

The Quality Assurance Manager will have a minimum five (5) years related experience in process improvement, analyzing information, strategic planning, verbal communication, informing others, emphasizing excellence, attention to detail, thoroughness, dealing with complexity and/or training and is qualified to lead and manage all aspects of the quality assurance process.

• Leads qualification and approval of Private Labeled (PLD) suppliers and subcontractors.
• Orders and monitors CV and other relevant product documentation for all suppliers.
• Provides input and quality oversight over investigations, including review of investigation reports and associated corrective and preventative action (CAPA) plans.
• Supports product complaint investigations ensuring timely response by CMOs.
• Monitors sterilization processes and vendors in relation to DSCSA.
• Performs lot disposition for materials received at 3PL.
• Supports CGMP compliance and inspection readiness within organization.
• Identifies and implements continuous improvement opportunities.
• Reviews records to ensure data…