QA Manager Development (562)

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 Assurance Manager will join the Civica, Inc. ("Civica") team in developing and supplying essential sterile injectable medicines to the United States by bringing their knowledge and experience to serve patients and pursue excellence in quality and compliance.

The Quality Assurance Manager will provide quality oversight within the Quality System, including but not limited to review and development of SOPs, protocols, reports, data and records generated to support the development and successful approval and commercialization of generic small molecule and biologic medications that meet business and operational requirements. The Quality Assurance Manager will ensure manufacturing processes developed are robust and compliant meeting FDA expectations. This position requires a broad range of knowledge and experience with sterile processes, drug development, and analytical testing methods.

Essential Duties and Responsibilities:

• Review and assess production and testing methods, specifications, validation protocols for analytical methods and method validation, reference materials, test results and reports created during product development.
• Partner with R&D and MSAT to develop documentation supporting technical transfer to Petersburg facility. 
• Assure risks to development programs are documented, escalated,and mitigations are addressed.
• Routine coordination and quality review of Contract Manufacturer Organization (CMO) Partners' documentation including batch record review for compliance to facilitate timely disposition of product lots.
• Support Petersburg site in any investigations, CAPAs for products being transferred into the facility
• Review regulatory filings for Civica products to assure data integrity and compliance to source documentation.
• Quality Systems: Working knowledge of the following quality systems: Change Control, CAPAs, Deviations, Technical Complaints/ Adverse Events, Management Reporting, and ,
• Support GMP compliance and inspection readiness within Civica and its suppliers.
• Reviews records to ensure data meets the industry requirements for data integrity.
• Ensures that procedures are being followed as outlined under FDA, ISO, USP and CGMP guidelines.
• Partners with Quality team members to implement centralized processes and ensures compliance to industry standards and compendia requirements.
• Coordinates in qualification and approval of suppliers for R&D products
• Assist in regulatory inspections.
• Promotes a quality mindset and quality excellence approach to all activities.
• Travel (up to 10-20%) may be required, including international travel.

Basic Qualifications and Capabilities:

• Bachelor's degree in a scientific discipline with a minimum of 8 years Quality/CGMP experience in the pharmaceutical industry. Experience in the manufacture of sterile injectable products required. 
• Working experience with analytical QC (method development, validation and sample analysis) including methods used for biologics (ELISA, bioassay)
• Demonstrated quality experience with manufacturing of sterile injectable products.
• Excellent written/oral communication skills with a strong discipline in Microsoft Programs is required Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment
• Ability to work autonomously within established guidelines, procedures and practices
• Committed to delivering high quality results, overcoming challenges and focusing on what matters
• Continuously looking for opportunities to learn, build skills and share learning
• Experience in drug substance manufacturing is a plus

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.