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 Systems Specialist will join Civica’s newly formed team at its Petersburg, Virginia, site by bringing their knowledge and experience in patient service 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 supports the Quality Systems Organization through compliance auditing of Civica’s Quality Systems (self-inspection), and as applicable, Civica’s Suppliers. The Quality Systems Specialist will support the assurance of compliance with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Documentation Practices), internal standards, 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 manage a compliance auditing program to ensure FDA requirements are met. 

Essential Duties and Responsibilities:

• Leads the Civica Petersburg Internal Audit (self-inspection) Program, including:
  • Creating and Executing the Annual Internal Audit Schedule
  • Leading Audit teams and mentoring Co-Auditors
  • Generation of audit reports
  • Support of auditees in the development of observation responses and remediation efforts
• Maintain current knowledge of applicable regulatory and legislative requirements and trends for pharmaceutical and medical device products regulated by the FDA to ensure that expert advice and appropriate technical support on quality related matters.
• Support 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.
• Support inspection readiness activities.
• Participate or lead the assessment, qualification, and approval of suppliers.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operational activities.
• Travel (up to 20%) may be required.

Basic Qualifications and Capabilities:

• Bachelor’s Degree in a scientific discipline and a minimum of 4+ years of experience directly related to the Essential Duties and Responsibilities of auditing. ASQ-CQA or other applicable Auditor Certification is preferred.
• Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
• 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.

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 essential duties of this position, the employee is regularly required to speak 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 this position requires 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, a drug-free workplace, and complies with ADA regulations as applicable.