Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.
Who suffers most? Patients.
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent 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 of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."
Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.
More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.
Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.
Learn more about Civica's plans and progress at www.civicarx.org
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 field with 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.
