ABOUT CIVICA

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. 

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines. 

Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.

Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.

To find out more about how Civica’s innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

POSITION SUMMARY 

Reporting to the Chief Manufacturing and Supply Chain Officer, the Head of Program Management, Civica Inc. will be responsible for coordinating critical activity needed to achieve commercial production of injectable medication at Civica Petersburg and at contract manufacturers, including development of Civica Petersburg products, facility construction, facility readiness, regulatory approval, and ERP implantation. This role also involves management of projects for potential acquisitions of Civica manufacturing sites and/or operations, development of Civica-owned packaging operations / distribution center(s), and related projects, as required. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Manage multi-functional and technical project teams to develop, gain regulatory approval, manufacture, and commercialize sterile injectable drugs.  Projects may include project management of the ANDA machine, for Civica Petersburg manufacturing and at our contract manufacturers.
• Manage product development, technical transfer, process qualifications/validations, facility construction, manufacturing capacity expansion, process equipment improvements, process scale-up and technical process improvements, contract manufacturing, efficiency improvements, and miscellaneous technical and project planning support. 
• Development and tracking of detailed project plans. (Examples include CRB Civica Petersburg construction, outsourcing of quality testing, launch of new Civica products and ERP implementation.) 
• Utilize expertise, experience and network to resolve issues. 
• Manage project costs and report on project financials. 
• Provide project risk management oversight. 
• Direct project(s) and project teams ensuring all necessary activities occur as planned.  
• Coordinate scheduling of project activities to meet deliverables. 
• Identify resource issues and utilize effective communication/leadership to ensure that satisfactory resolution occurs. 
• Maintain close contact with both Civica and external partner representative(s) through meetings, site visits, teleconferences, and other forums to ensure that issues are addressed, and project timeline activities are met. 
• Serves as primary contact and communication link between Civica and external project partners and companies. 
• Meet regularly with project team members to understand technical, quality, and financial issues as related to the project(s).  
• Prepare and present project updates to Civica executive and advisory committees, as necessary. 
• Solicit other projects that are aligned with Civica goals & objectives. 
• Develop and implement standard project/program management systems, procedures, checklists/tools, documentation practices, reporting, etc. 
• Through direct and/or matrix reporting, provide oversight and direction to other team members (internal and external) providing project management support to assure standard practices are followed and systems utilized in providing all necessary integration of individual projects and/or milestones into overall program management/tracking. 
• Perform other duties as assigned.

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)

• 8+ years of relevant project management experience in related industry. 
• BS /BA in a relevant discipline, e.g. project management, engineering, R&D, operations management, or similar is required.  
• Experience in pharmaceutical operations/cGMP environment. 
• Ability to work with a variety of technical disciplines. 
• Knowledge of and significant proficiency in project management software, such as Microsoft Project and others. 
• Demonstrated ability to effectively communicate and negotiate a diversity of issues. 
• Strong interpersonal and communication skills, both verbally and written, at all levels within Civcia and external partner organizations. 
• Ability to effectively collaborate with others to achieve team goals and expectations. 
• Effective time management and prioritization skills. 
• Outstanding organization skills and attention to detail. 
• Self-starter, mature, independent and dependable. 
• Ability to work in a fast-paced environment under pressure, able to multi-task and obtain results. 
• Ability to maintain high degree of confidentiality and use of appropriate discretion and independent judgment.