Quality Assurance Manager- Biologics/Combination

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 Biologics/Combination Products Manager 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 and biosimilar insulin sterile injectable and associated combination product medications.  Responsibilities of the position include establishing and maintaining quality and compliance processes associated with sterile manufacturing and operations of biosimilar insulins and associated combination products from the onset of qualifying the facility and equipment and leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications. 

Responsibilities also include, but are not limited to, batch record review and release of biologic similar insulin bulk drug substance and sterile fill finish vials and pre-filled injectable pen  products; developing policies and procedures and other records necessary to support the design, implementation, and maintenance of manufacturing processes that meets or exceeds FDA requirements. 

Essential Duties and Responsibilities:

• Working across functions, lead the establishment and maintenance of the site’s quality systems related to biological/biosimilar and associated combination product manufacturing and packaging operations to enable the development and reliable supply of Civica medications to patients.
• Responsible for all operational compliance aspects of sterile fill finish manufacturing of biological/biosimilar and associated combination products including but not limited to: batch record review, and batch release. 
• Ensure that all aspects of the handling, manufacturing, and distribution of pharmaceutical products at the site comply with Civica and relevant cGMP regulatory requirements.
• Ensure Standard Operating Procedures, and training is in place to maintain compliance with cGMP.    
• Provide leadership, direction, and support to the people within the Quality Assurance Operations department.
• Maintain current knowledge of local and international biologics and combination regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
• Support and ensure compliance of biological/biosimilar and associated combination products and process transfers, including validation, from and/or to other manufacturing sites.
• Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
• Participate in or lead quality risk analysis.
• Participate in quality oversight of clinical trials.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operations activities.
• Travel (up to 10%) may be required.

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 biological and combination products (i.e., pre-filled injectable pens)
• Experience in sterile injectable manufacturing and packaging operations is required.
• Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
• Quality assurance experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
• Participation and leading activities to support regulatory agency inspections required.
• Excellent interpersonal and written communication skills and experience 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.

Preferred Qualifications:

• Experience with clinical trials.