Senior Manager, Operational Technology (921)

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 Senior Manager of Operational Technology plays a critical leadership role in Civica’s pharmaceutical organization, overseeing the operation and integration of operational technology (OT) systems at the Petersburg site. The Petersburg site serves as Civica’s new fill-finish facility, dedicated to manufacturing and supplying essential generic sterile injectable medications.

You will play a critical role in ensuring our OT data systems' integrity, security, and reliability and maintaining compliance with regulatory standards. You will collaborate closely with cross-functional teams, including Engineering, Manufacturing, IT, and Quality.

Essential Duties and Responsibilities:

• Operational Technology Management:
  • System Architecture: Oversee the design, implementation, and maintenance of OT systems, including process control, automation, and manufacturing execution systems.
  • Risk Assessment: Evaluate risks associated with OT systems and develop mitigation strategies. Ensure robust cybersecurity measures to protect critical infrastructure.
  • Vendor Management: Collaborate with vendors and third-party providers to ensure seamless integration of OT solutions. Evaluate vendor compliance with data integrity standards.
• Responsible for all technology-related system integrations across different software platforms and systems.
• Maintain infrastructure systems, disaster recovery, and systems/network security with the systems engineering team. Responsible for Disaster Recovery and Business Continuity initiatives.
• Facilitates IT security audits and or investigations.
• Analyzes IT infrastructure and systems performance to assess operating costs, productivity levels, upgrade requirements, and other metrics and needs.
• Ensure operational requirements and coordinate with system requirements for future growth and strategy to align with highly available applications and systems.
• Lead, develop, review, and approve detailed specifications, engineering documents, SOPs, test scripts, and engineering standards