Quality Systems Specialist II – Data Integrity (388)

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 II for Data Integrity will join the Civica, Inc. (“Civica”) organization and its newly forming 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 injectable medications.

Responsibilities of the position include oversight of Civica Petersburg Site’s data governance program and ensuring appropriate data integrity controls are in place to protect data throughout the data lifecycle. The role is essential to assure the Petersburg site’s data governance program complies with applicable regulatory standards (e.g., Current Good Manufacturing Practices) and expectations for the development and reliable supply of quality medicines.

Essential Duties and Responsibilities:

• Responsible for maintaining data governance program, including design (i.e., establishment of data process flows, assignment of risk rankings, identification of required controls), operation support (e.g., business process/GXP computerized system data integrity issue investigation), and monitoring.
• Provide mentorship and advice on approved procedures, standardization and requirements associated with the quality management system (QMS) and data integrity, including ALCOA+.
• Lead data integrity investigations and work cross functionally to determine root cause and CAPAs.
• Support audit trail reviews.
• Analyze metrics to measure the effectiveness of the data governance program.
• Subject Matter Expert and Key User supporting data integrity and good documentation practices (GDocP).
• Identify and raise data integrity compliance gaps across the quality system.
• Develop and deliver training to new staff on data integrity and other processes and procedures.
• Support audits (internal, regulatory).
• Support inspection readiness activities.
• Promote a culture of quality and drive enthusiasm for data integrity compliance.
• Execute critical initiatives to improve the quality system and data integrity.
• Perform other duties as required.

Basic Qualifications and Capabilities:

• Bachelor’s degree with 6+ years of combined technical experience in a GMP related field within a pharmaceutical/biologics manufacturing facility.
• Exp