Manager, Computerized Systems at Civica Rx

AboutCivica

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veterans Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.

Civicarecently announced plans to expand its mission, via a unit called CivicaScript, into the outpatient pharmacy space and to manufacture and distribute insulin that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulin, beginning in 2024, will benefit people with diabetes who have been forced to choose between life medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.

Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.

To find out more about how Civica's innovative model is directly impacting patientcare, click here to read a summary from the NewEngland Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Job Description

The Computerized System Manager for Laboratory IT oversees the implementation, validation, and maintenance of the computerized systems supporting GxP Laboratory Operations. You will be responsible for ensuring the laboratory systems' compliance, quality, and efficiency and maintaining data throughout the data lifecycle.

Essential Duties and Responsibilities:

• Manage existing LIMS and CDS systems and drive the selection, installation, testing, maintenance, training, and support of additional laboratory systems.
• Ensure the laboratory systems and data comply with the regulatory requirements, industry standards, and best practices for data integrity, security, and quality.
• Implement and monitor data integrity controls, such as user access, audit trails, backups, electronic signatures, data review, and data transfer, to ensure the laboratory data's accuracy, completeness, consistency, and availability.
• Manage the integration, validation, and maintenance of stand-alone lab instruments and ensure their compatibility and connectivity with laboratory systems and data.
• Perform system administration tasks for Empower, such as creating and managing projects, users, groups, privileges, instruments, methods, custom fields, etc.
• Troubleshoot and resolve any issues related to Empower, such as network, database, instrument, or software problems.
• Coordinate with vendor and ensure the proper configuration, upgrade, backup, and recovery of the Empower system.
• Collaborate with cross-functional stakeholders to understand the laboratory needs and deliver computerized system solutions that enable analytical excellence and data integrity controls.
• Manage the computerized system budget for Laboratory Systems, resources, and vendors, ensuring the optimal utilization and allocation of the system assets and services.
• Cross-train to provide backup support for other Site IT needs.
• Monitor and report on the computerized system performance, risks, and issues, and implement corrective and preventive actions as needed.
• Identify and drive computerized system innovation and improvement opportunities, leveraging new technologies and methodologies.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• A bachelor's degree in computer science, engineering, or a related fieldwith 8+ years of experience in computerized system roles in the pharmaceutical or biotechnology industry.
• A strong knowledge of the computerized system principles, standards, and regulations, such as GAMP 5, 21 CFR Part 11, EU Annex 11, etc.
• A solid understanding of laboratory processes, systems, and technologies, including LIMS and CDS.
• A familiarity with the stand-alone lab instruments, their functions, and their requirements, such as calibration, qualification, and data transfer.
• Experience implementing data integrity controls.
• Proficiency in the Empower system, its features, and its administration, such as creating and managing projects, users, groups, privileges, instruments, methods, custom fields, etc.
• Experience in troubleshooting and resolving issues related to Empower, such as network, database, instrument, or software problems.
• Capable of working independently against deadlines in a fast-paced, and dynamic environment.
• High level of analytical, problem-solving, and decision-making skills.
• Excellent communication, collaboration, and leadership skills.

Preferred Qualifications:

• Experience with MODA LIMS preferred.
• Advanced experience in project management and change management.
• Strong knowledge of computerized system validation
• Experience with ELN and implementation of paperless lab.