Associate Director Biologics Quality Assurance (371)
Civica

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 Associate Director Biologics Quality Assurance is a highly motivated technically knowledgeable leader with proven abilities to guide and execute quality assurance activities in drug product manufacturing. This is an exciting opportunity to be part of the team developing, manufacturing, and launching insulin biosimilars to patients seeking options for affordable insulin. The Associate Director Biologics Quality Assurance
will have oversight of all documentation related to the insulin filling transfer and startup. The Associate Director Biologics Quality Assurance will report to the Director of Biologics quality and will be part of a dedicated insulin team at our Civica Petersburg, Virginia state of the art formulation and filling facility. This position requires a deep knowledge of drug product operations with an emphasis on hand on manufacturing floor experience.

Essential Duties and Responsibilities:

• Review and approve quality system records including change requests, deviations, and CAPA as necessary.
• Review and approve validation/qualification of insulin biosimilars and escalation of issues to management.
• Provide manufacturing shop floor support to achieve smooth facility startup
• Influence across the organization to establish a culture of excellence and right-first-time execution.
• Disposition of drug substance from external partners.
• Review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), Quality Plans related to manufacturing operations, as needed.
• Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations. Working in clinical manufacturing is a plus.
• Able to work in cross functional teams to achieve team goals
• Partner and influence other departments and functions throughout the organization, including Operations, site Quality, Regulatory Affairs, MST, and R&D etc. to implement ongoing product/process robustness to continuously improve.

• Extensive experience in the pharmaceutical or biotechnology drug product manufacturing
• Demonstrated experience within a quality oversight function.
• Bachelor's degree or higher in Life Sciences, Chemistry, Biology, Engineering or a related field.
• Hands-on experience with oversight of GMP operations at drug product facilities.
• Preference given to experience in facility start ups
• Ability to synthesize data and provide compliant and pragmatic recommendations to stakeholders.
• Ability to collaborate and manage conflict in a fast-paced environment.
• Excellent interpersonal, verbal, and written communication skills.