Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration's shortage list. Manufacturing challenges and predatory pricing are both the cause and result.
Who suffers most? Patients.
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. Led by an experienced team of health care and pharmaceutical industry leaders.
Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent 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 is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been Do What Is in the Best Interest of Patients.
Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs.
To find out more about how Civica's innovative model is directly impacting patient care, click here to read a recent article from the New England Journal of Medicine.
The Quality Systems Manager will join the 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 sterile injectable medications. Responsibilities of the position include establishing and maintaining the quality system framework at the onset of building and qualifying the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications. The role is essential to assure the Petersburg site's quality management system complies with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines. This role is responsible for leading the quality systems team and developing quality systems and processes to enable the manufacture of sterile injectable medications. Responsibilities also include but are not limited to, the generation, review and/or approval of policies, procedures, reports, and other records necessary to support the design, implementation, and maintenance of a robust quality management system that meets or exceeds FDA requirements.
Essential Duties and Responsibilities:
Working across functions, lead the establishment and maintenance of the site's quality system framework including quality systems and processes necessary to enable the development and reliable supply of Civica generic medications to patients.
Develop and/or improve 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.
Track, trend, and analyze quality system data and information for the site including, but not limited to change controls, corrective and preventive actions, audit findings, deviations, complaint information, notifications to management, and health authority communications and notifications. Recommend action and continuous improvement plans. Summarize findings and recommendations for management and team awareness and/or present at routine Quality Council meetings.
Participate or lead the assessment, qualification, and approval of suppliers.
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.
Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
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 management experience in the pharmaceutical industry.
Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
Quality system management 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.
Minimum of 2 years experience in a supervisory role highly desired.
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.
Technical expertise in pharmaceutical and combination product, process, and/or method development and validation.
Experience in sterile injectable isolator technology, facility qualification and combination products.
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.