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||Petersburg, VA United States
|| Biotechnology and Pharmaceutical
Quality Systems Manager |
Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company created by hospital systems and philanthropies, Civica's mission is to reduce and prevent drug shortages while assuring quality generic medicines are accessible and affordable to everyone.
Because the United States experiences chronic shortages of essential generic medicines used daily in hospitals, we are building a state-of-the-art sterile injectable manufacturing facility to combat these shortages. This new facility is part of our broad strategy to stabilize the supply of generic medicines for emergency rooms, surgeries, COVID-19 patient care, and an array of other serious conditions.
WHO CIVICA SERVES
While serving 50 health systems and 1,350 hospitals (or 30% of all licensed U.S. hospital beds), Civica also supplies the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and “340B” hospitals caring for vulnerable patients in some of the country's most underserved areas. And recently, Civica contributed more than 2-million vials of essential medications to the strategic national stockpile.
With 40 sterile injectable medications under contract to supply our member hospitals, Civica is growing and on track to have 100 drugs under contract by 2023.
As we continue to grow, we have many exciting opportunities for multiple types of roles and with opportunity to progress YOUR career.
The Quality Systems Manager will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site (just outside of Richmond) 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. 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.
Qualifications & Requirements
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. Experience in sterile injectable isolator technology, facility qualification and combination products highly desirable.
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 highly desirable.
Salary DOE. Excellent benefits.
Over the past two decades, shortages of generic, injectable drugs critical to the lifesaving work of hospitals in the United States have become commonplace. These drug shortages are so ubiquitous that hospitals and health care systems now maintain permanent drug shortage response teams that seek alternatives to unavailable drugs.
As a result, time that hospital pharmacists, technicians, nurses and others would prefer to spend caring for patients is spent ensuring that the patients who most need short-supply drugs get whatever supply is available.
Civica was created to reduce and prevent drug shortages and the price spikes that can accompany them. Its mission is to make quality generic medicines accessible and affordable to everyone.