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 Managerwill join the Civica, Inc. (“Civica”) team in supplying essential genericquality medicines to our hospital members in the United States by bringingtheir knowledge and experience to serve patients and pursue excellence in qualityand compliance.

The Quality Assurance Managerwill provide quality oversight within the Quality System, including but notlimited to review of SOPs, protocols, reports, data and records generated tosupport the disposition and distribution of pharmaceutical product to meetbusiness and operational requirements. The Quality Assurance Manager willdevelop processes and procedures in support of the Quality Management systemconsistent with Food and Drug Administration (FDA) regulations and current goodmanufacturing practices (CGMPs).

The Quality Assurance Managerwill have a minimum five (5) years related experience in process improvement,analyzing information, strategic planning, verbal communication, informingothers, emphasizing excellence, attention to detail, thoroughness, dealing withcomplexity and/or training and qualified to lead and manage all aspects of thequality assurance process. 

Essential Duties andResponsibilities:

• Leadsqualification and approval of Private Labeled (PLD) suppliers andsubcontractors.
  • Workswith supply chain to assure serialization is completed with PLD suppliers
  • LeadsQuality Agreement negotiations with CMO Partners
• Routinecoordination and quality review of Contract Manufacturer Organization (CMO)Partners’ documentation including batch record review for compliance tofacilitate timely disposition of product lots.
• Providesinput and quality oversight over investigations, which includes review ofinvestigation reports and associated corrective and preventative action (CAPA)plans.
  • Manageschanges coming from the CMOs within the Civica Quality System
  • Partnerswith supply chain to ensure issues are resolved by the CMO to maintain product availability
• Supportproduct complaint investigations ensuring timely response by CMOs
• Monitorserialization processes and vendors in relation to DSCSA.
• Performlot disposition for materials received at 3PL.
• SupportCGMP compliance and inspection readiness within organization.
• Identifyand implement continuous improvement opportunities
• SupportCGMP compliance and inspection readiness within organization.
• Reviewsrecords to ensure data meets the industry requirements for data integrity.
• Ensuresthat procedures are being followed as outlined under FDA, ISO, USP and CGMPguidelines. 

Minimum Qualifications andCapabilities:

• Bachelor’s degree in ascientific discipline with a minimum of 5 years Quality/CGMP experience in thepharmaceutical industry. Experience in the manufacture of sterile injectablepharmaceutical products required.
• Excellent written/oralcommunication skills with a strong discipline in Microsoft Programs isrequired.
• Self-motivated, flexible, andable to work in a small, fast-paced, dynamic, environment.
• Ability to work autonomouslywithin established guidelines, procedures and practices.
• Committed to delivering highquality results, overcoming challenges and focusing on what matters.
• Continuously looking foropportunities 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.