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

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 oversight of the quality management system (QMS) change management program.

The role is essential to assure the Petersburg site’s Change 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

• Responsible for the Quality Management System oversight and execution of the Change Control Program.
• Reviewing, editing, and approving change control documentation to ensure compliance with quality, regulatory and SOP requirements.
• Scheduling and facilitating cross functional change control meetings and providing guidance and consultation to change control owners.
• Facilitate, monitor, and drive change control on time completion.
• Support overall quality system programs as needed to include but not limited to document control, supplier, and investigation systems.
• Track, trend, and analyze QMS information for the site.
• Developing collaborative relationships with end users and providing guidance on standard processes in Change Control.
• Act as the site’s subject matter expert on changed control.
• Partnering with members of the Quality Assurance team and/or end users of the system to promote continuous improvements to the Change Control system, process, and associated procedures.
• Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation.
• Support cGMP compliance and inspection readiness within the organization.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
• Fosters the development of a Quality Culture within the cGMP environment.
• Practice and promote a safety and quality mindset and quality excellence approach to all activities.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree with a minimum of 3 years document control experience within a regulated industry or a combination of equivalent education and experience.
• Managed or participated in a cGMP Change Management program.
• Strong organization, and execution skills with an attention to detail.
• Ability to successfully managing multiple priorities.
• Excellent interpersonal and written communication skills
• Experience with Electronic Documentation Management Systems. using various software/electronic applications required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• 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 taking risk-based and compliant approaches to solutions.

Preferred Qualifications:

• Previous experience working with Veeva.