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 Civica Script, to into the outpatient shop 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. ( 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 Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Job Description: The Associate Director Quality Control 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 sterile injectable medications.
Responsibilities of the position include establishing and maintaining quality control chemistry laboratories and sample management programs. Responsibilities also include analytical readiness for new product introduction and management of Civica’s marketed stability program. The role is essential to assure the Petersburg site’s programs comply 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: Oversight and management of Quality Control (QC) testing for the Petersburg Site to ensure compliance with c GMPs and product quality. Oversight and management of the in-process laboratory and associated testing. Oversight and management of incoming material testing. Oversight and management of shipping samples to contract testing laboratories. Oversight and management of testing data and evaluation of results. Establish processes and procedures for a future Civica owned and operated QC release testing laboratory. Direct team to ensure compliant and on time establishment and verification, validation, and transfer of QC methods.
Responsible for establishing and maintaining Civica’s marketed life stability program. Guide and develop team, leveraging individuals’ experiences and skills to create challenging and meaningful work opportunities. Guide multi-functional teams to accomplish goals, providing guidance, encouraging team performance, and recognizing and rewarding collaborative behaviors. Represent the organization with third party laboratory for routine release and stability testing. Lead and/or participate in investigations related to laboratory operations and non-conforming results.
Identify, track, and facilitate resolution of technical issues. Participate or lead quality risk management backssments as required. Proactively identify and work collaboratively to resolve problems, taking risk-based and compliant approaches to solutions. Author and/or review and approve SOPs, protocols, reports, test method and product specification documents as applicable. Promote a quality mindset and quality excellence approach to all activities. Travel (up to 5%) may be required. Basic Qualifications and Capabilities: Bachelor’s degree in a scientific discipline with a minimum of 12 years Quality/CGMP experience in the medical industry.
Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities. QC laboratory experience across the product development and commercialization lifecycle. Stability program experience for marketed life programs. 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.
