Quality Assurance Manager

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 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 of five (5) years of 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.

Essential Duties and Responsibilities

Lead qualification and approval of Private Labeled (PLD) suppliers and subcontractors.

Work with supply chain to assure serialization is completed with PLD suppliers.

Lead Quality Agreement negotiations with CMO Partners.

Routine coordination and quality review of Contract Manufacturer Organization (CMO) Partners’ documentation including batch record review for compliance to facilitate timely disposition of product lots.

Provide input and quality oversight over investigations, which includes review of investigation reports and associated corrective and preventative action (CAPA) plans.

Manage changes coming from the CMOs within the Civica Quality System.

Partner with supply chain to ensure issues are resolved by the CMO to maintain product availability.

Support product complaint investigations ensuring timely response by CMOs.

Monitor sterilization processes and vendors in relation to DSCSA.

Perform lot disposition for materials received at 3PL.

Support CGMP compliance and inspection readiness within the organization.

Identify and implement continuous improvement opportunities.

Review records to ensure data meets industry requirements for data integrity.

Ensure procedures are being followed as outlined under FDA, ISO, USP, and CGMP guidelines.

Minimum Qualifications and Capabilities

Bachelor’s degree in a scientific discipline with a minimum of 5 years Quality/CGMP experience in the pharmaceutical industry. Experience in the manufacture of sterile injectable pharmaceutical products is required.

Excellent written and oral communication skills with 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.

Preferred Qualifications

Experience with commercial distribution of pharmaceuticals is preferred.

Experience with quality support of serialization processes is preferred.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.

Learn more here