Head Of Quality Systems

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 Head of Quality Systems leads the deployment and improvement of the Quality Management System (QMS) at Civica that ensures a high state of cGMP compliance and supports the effective execution of Civica objectives, including lifecycle management of policies and procedures for processes that govern all GxP related activities. Also, leads the following quality management systems: Documentation, Change Management, Investigation/Deviation and CAPA, Complaints, IT Quality, and Training. Additionally, is the owner of Electronic Systems associated with Documentation Management, Deviations/CAPA Management, Change Management and Learning Management.

Essential Duties and Responsibilities:

• Establish, and maintain the global QMS elements including policies, processes, procedures and controls, enabling successful and efficient development and manufacturing of drug products meeting Civica and regulatory requirements.
• Establish and maintain risk-based, fit-for-purpose Quality Management System.
• Oversee the pharmacovigilance program ensuring robust reporting and investigations.
• Responsible for the electronic quality management system (VEEVA) and ensuring the system maintains its validated state.
• Develop robust systems to assure corrective and preventive measures are systematically implemented and controlled.
• Propose and drive continuous improvements to the Quality Management System to streamline business processes and stay in compliance with external requirements (e.g., regulatory).
• Design and maintain trending program for quality events/ laboratory controls/ production controls by key indicators (e.g., dates, categories, root causes, and CAPA) to identify adverse trends/ risk to help drive continuous improvement for manufacturing/ production controls and laboratory controls per Civica GxP procedures.
• Ensure Computer System Validation (CSV) processes are fully implemented with the appropriate quality oversight.
• Develop and implement Medical Device Reporting (MDR) processes for combination products.
• Support and ensure the governance of any other initiatives as delegated.
• Establish and maintain Quality Plan.

Basic Qualifications and Capabilities:

• Minimum 15 years of life science/pharmaceutical/biologics product manufacturing and development experience.
• Bachelor’s degree in a science, pharmacy, or engineering discipline. Advanced degree desired.
• Broad knowledge and experience with quality assurance and quality system, regulatory compliance and understanding of current regulatory requirements and trends for manufacturing drug substance, drug product and combination products, in particular sterile injectable medications.
• Prior experience managing personnel.
• Working knowledge of software solutions for QMS.
• Strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment.
• Strong project management skills with an emphasis on critical thinking and problem solving.
• Demonstrated ability to apply risk-based approaches to Quality Systems implementation, and maintenance.
• Extensive experience in hosting FDA inspections, keeping pace with ongoing updated regulations and requirements, and as applicable especially 21CFR211, 21CFR820/803/806.