Manager, Visual Inspection at Civica Rx

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-/)

Position Summary

The Manager, Visual Inspection is accountable and responsible for management of the manual and automated Visual Inspection program at Civica, including defect library, knapp test kits, AQL strategy, and inspection qualification. This is a leadership role with focus on the start-up, execution, and maintenance of GMP inspection program, compliant to USP 790 and 1790. Will support commissioning/qualification activities required to bring automated vision systems into service as well as supporting site operational readiness activities. This role is a subject matter expert for the visual inspection equipment/process and will perform various duties related to maintaining compliance and the continuous improvement of the visual inspection program.

Essential Duties and Responsibilities

• Partner with Technical Services, Quality, Manufacturing and Engineering leadership to deliver functionally strong and operationally centered results.
• Experience using and / or developing qualification kits and qualifying operators.
• Assist in classification of rejected units.
• Assist with development and evaluation of inspection parameters & techniques for new products, and continued optimization of parameters for existing products.
• Develop, write, review, and approve SOPs, specifications, and other documents to support the manual/automated visual Inspection, packaging, and AQL sampling.
• Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
• Understand and influence the manufacturing control strategy for automated visual inspection.
• Actively participate in new equipment and process qualifications.
• The ability for direct interaction with Regulatory Agencies during site inspections.
• Ensure that the Visual Inspection Program operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
• Mentors, coaches, and develops the Visual Inspection Team to ensure timely completion of projects at the expected results.
• Assist Engineering, Maintenance, Quality, and Product Development in assuring implementation of robust processes.
• Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Visual Inspection.
• Identify corrective and preventive actions (CAPA), lead project to completion within project timelines. Verify effectiveness of CAPA by post-project data collection and analysis.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Advanced knowledge of Current Good Manufacturing Practices (cGMP), FDA, USP, OSHA, EPA, DEA; other regulatory requirements.
• Advanced knowledge of Visual inspection principals, practices, and applications.
• Knowledge of Lean Six Sigma Tools and DMAIC problem solving approaches.
• Demonstrated excellence in oral and written communication.
• 7+ years demonstrated ability in a GMP FDA, cGMP, ISO, or other regulated production environments.
• At least 3 years previous management or leadership experience including leading or working effectively with a cross functional group.
• Bachelor's degree in a science related field; Equivalent education and experience may be considered.

Additional Preferences:

• Excellent interpersonal, written and oral communication skills.
• Strong technical aptitude and ability to train and mentor others.
• Ability to handle multiple competing priorities.
• Solid understanding of basic requirements of regulatory agencies.
• Previous facility or area start up experience.
• Previous experience in operations and engineering.
• Previous experience with highly automated equipment.
• Previous experience with combination products, device assembly, pharmaceutical packaging, and filling in aseptic environment.
• Previous equipment qualification and process validation experience.
• Previous experience with deviation and change management systems including Veeva.