Manager, Computer System Validation (248) - civica rx : Job Details

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 Manager, Computer System Validation will join the Civica, Inc. (“Civica”) Information Technology organization at the Petersburg, Virginia site, responsible for ensuring that all computer systems and data integrity processes comply with regulatory GMP / GXP requirements and internal standards. This role involves validating on-premises and cloud-based platforms, software, and hardware systems, maintaining data integrity, and supporting audits and inspections. This position collaborates with cross-functional teams to implement and maintain validated GXP systems that support business operations and regulatory compliance.

Essential Duties and Responsibilities:

• Collaborate with Business System Owners, Technical Owners, System Administrators, Engineering, Information Technology, Quality Assurance, and other departments to implement validated GMP / GXP systems.
• Ensure compliance with GMP / GXP regulatory requirements and frameworks such as U.S. Food and Drug Administration (FDA) 21 CFR Part 11, Annex 11, GAMP 5, and other applicable standards.
• Develop and execute validation deliverables, policies, and procedures for computer systems and data integrity processes. Computer system validation activities include but are not limited to the following: requirements gathering, validation planning, IQ/OQ/PQ protocol generation, test execution, requirements traceability matrices, system configuration specifications, and validation summary reports.
• Review and approve system risk and data integrity assessments, and periodic review reports to ensure that GMP / GXP computerized systems remain compliant, secure, and fit for their intended use throughout their lifecycle.
• Conduct impact assessments for new systems and system changes.
• Support internal and external audits by providing validation documentation and expertise.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all computer system validation related matters is provided to the company with a focus on data integrity.
• Train staff on computer systems validation procedures and data integrity processes / best practices.

Minimum Qualifications (Knowledge, Skills, and Abilities):

• Bachelor's degree in the field of Computer Science, Engineering, Life Sciences, or a related field.
• 8+ years of experience in computer system validation and data integrity in a regulated GMP / GXP environment.
• Strong knowledge of regulatory requirements and industry standards (e.g., FDA, GAMP, ALCOA++).
• Experience with validation tools, documentation, and system development lifecycle management.
• Excellent leadership, project management, analytical, organizational, and communication skills.
• Ability to work independently and collaboratively in a team environment.

Preferred Qualifications:

• 10+ years of experience in the pharmaceutical industry, specifically in the computer system validation arena supporting sterile injectable manufacturing.
• Data Process Flow Mapping techniques used in GMP / GXP data integrity processes to ensure compliance, traceability, and risk mitigation in regulated environments.
• Experience with Veeva Vaults, Enterprise Resource Planning systems, computerized maintenance management systems, laboratory automation systems, Manufacturing
• Execution Systems, and manufacturing control systems.

Physical Demands and Work Environment:

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 this position requires include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.