Senior Quality Engineer - 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 savingsto bepassed 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 Senior Quality Engineer for Data Integrity will join the Civica, Inc. ("Civica") organization and the 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 and biosimilar 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. As the Data Integrity Lead for the site your 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 the Site's 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.
• Partner across the organization leading Data Governance and Data Integrity initiatives and assessments.
• Establish Data Integrity related procedures, work instructions and assessments.
• Support standardization and requirements associated with the quality management system (QMS), data governance and data integrity, including ALCOA++.
• Lead data integrity investigations and work cross functionally to determine root cause and corrective and preventative actions.
• 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 and drive CAPA generation and resolutions.
• Develop and deliver training to new staff on data integrity and other processes and procedures.
• Support Health Authority inspections as the SME for data integrity.
• 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 :

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 accommodation 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 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.

J-18808-Ljbffr