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-/)

Job Description:

The Quality Systems Associate will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica’s new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

Responsibilities of the position include but are not limited to oversight of Civica Petersburg Site’s supplier quality management program.

The role is essential to assure the Petersburg site’s supplier quality management program complies with applicable regulatory standards (e.g., Current Good Manufacturing Practices) and expectations for the development and reliable supply of quality medicines.

Essential Duties and Responsibilities:

• Lead the site’s supplier quality management program to enable the development and reliable supply of Civica generic medications to patients.
• Working across functions to ensure suppliers are identified for inclusion in the supplier management program.
• Author or support development of quality agreements.
• Support evaluation of metrics to measure the effectiveness of the supplier quality management program.
• Act as subject Matter Expert for supplier quality management for the site.
• Identify and raise supplier quality concerns identified through the design, operation, and monitoring of the supplier quality management program.
• Develop and deliver training to staff for supplier quality management processes and procedures.
• Support inspection readiness activities and regulatory inspections.
• Promote a culture of quality and drive enthusiasm for CGMP compliance.
• Perform other duties as required.

Basic Qualifications and Capabilities:

• A minimum of 4 years of combined technical experience in a GMP related field within a pharmaceutical, biologics, or medical device manufacturing facility.
• Experience with Quality systems and demonstrated working knowledge in areas such as material/process controls, supplier quality management, audits, change control, deviation, CAPA, Management Review.
• Experience with cGMPs and Quality System regulatory requirements.
• Experience with Quality computerized system applications (e.g., Veeva, Deacom)
• Works on multiple assignments in collaboration with various department system owners.
• Excellent interpersonal, verbal and written (including editing) communication skills are crucial in this collaborative work environment.
• Ability to communicate and work independently with scientific/technical personnel.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Strong organization, and execution skills with an attention to detail.
• Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills and share knowledge with others.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.