Manager, Visual Inspection (341) - Civica Rx

About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica’s plans and progress at  www.civicarx.org

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.