Associate Director of Information & Operational Technology - 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 Associate Director of Information & Operational Technology (I&OT) leads Civica's infrastructure, networks, cybersecurity, and compliance efforts for the Petersburg site. This role ensures security, reliability, and regulatory compliance. The candidate will partner with a team of I&OT professionals and consultants, collaborating with cross-functional stakeholders to integrate systems seamlessly. Essential Duties and Responsibilities: Develop and implement strategies for integrating I&OT systems to enhance operational efficiency and security.Collaborate with cross-functional stakeholders to design, develop, and maintain I&OT Networks and Cybersecurity needs in GMP and non-GMP areas.Drive the development of policies and innovative computerized solutions to achieve results.Responsible for all technology-related system integrations across different software platforms and systems such as Asset Management System, Active Monitoring System, Operator Management and Access Control System, Alarm Management System, Disaster Recovery System, Historians.Manage yearly budgets.Develop and implement strategies to ensure data integrity and compliance across I&OT systems.Define and enforce Management of Change process through cross functional collaboration.Collaborate with vendors and third-party providers through the entire lifecycle of projects.Proficient with 21 CFR part 11.Lead, develop, review, and approve detailed specifications, engineering documents, SOPs, test scripts, and engineering standards in compliance with site procedures and industry standards.Define processes and tools to improve predictability and reliability of I&OT Systems.Educate other I&OT and automation colleagues in the site technologies, I&OT procedures, and industry standards.Consistently leading by example, being a role model and change agent for all team members and the corporate technology team. Minimum Qualifications (Knowledge, Skills, and Abilities) Bachelor's degree in engineering, Information Technology, or related field (Master's Degree preferred).Minimum 12+ years of experience in architecting, planning, implementing, and maintaining IT & OT solutions in a regulated environment.Experience with cybersecurity frameworks and standards (e.g., NIST, IEC 62443).Demonstrated experience with designing and integrating complex OT systems with IT.Demonstrated experience with integrating multiple IT & OT systems to drive operational and security objectives.Excellent collaboration, oral, and written communication skills, including the ability to communicate/translate technical concepts in a business framework.Ability to build collaborative relationships and productive working partnerships across cross-functional teams.Ability to work through and manage ambiguity to drive decisions in complex, fast-paced, and dynamic environment.Demonstrated ability to effectively lead and influence leaders and team members to choose new working methods.Knowledge of pharmaceutical manufacturing processes, regulatory requirements, data integrity guidelines, and FDA expectations. Preferred Qualifications: Certifications such as IEC62443, GICSP or PMP (Project Management Professional) are advantageous.Experience in sterile fill-finish facility manufacturing.Experience with regulatory inspections.Programming Switches, Firewalls, and custom scripts.Experience with Thin Clients, SQL Server design, implementation, and support. Physical Demands and Work Environment : The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this position. Reasonable accommodations 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, a drug-free workplace, and complies with ADA regulations as applicable. PandoLogic. Category: General