Associate Director of Information & Operational Technology (921)
Civica

About Civica:

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 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.

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