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 below to read a recent article from the New England Journal of Medicine.
The Quality Assurance - Operations Supervisor 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 sterile injectable medications.
The role is essential to assure the Petersburg site's manufacturing and operations activities comply 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 of the position include establishing and maintaining quality and compliance processes associated with sterile manufacturing and operations from 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.
Responsibilities also include, but are not limited to, shop floor oversight and the generation, review and/or approval of policies, procedures, reports, batch records and other records necessary to support the design, implementation, and maintenance of manufacturing processes that meets or exceeds FDA requirements.
Essential Duties and Responsibilities
Working across functions, establish and maintain the site's quality systems related to manufacturing operations to enable reliable supply of quality generic medications to patients.
Promote a quality mindset and quality excellence approach to all activities.
Promote a safety mindset and focus on safety for all operations activities.
Responsible for operational compliance aspects of sterile fill finish manufacturing of products including but not limited to aseptic process simulations, terminal sterilization, batch record review, batch disposition, and shop-floor quality.
Ensure that all aspects of the handling, and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
Establish and maintain Standard Operating Procedures and training consistent with CGMPs for QA shop-floor support.
Provide leadership, direction, and support to ensure shop floor associates and operators are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.
Maintain written procedures and associated records for personnel qualification and training and support the delivery of compliance training sessions.
Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing.
Support, review and approve equipment qualifications and product and process transfers, including validation, from development and/or other manufacturing sites.
Establish and maintain Standard Operating Procedures, and training to ensure raw materials, excipients, APIs and components are qualified and their suppliers are approved in accordance with Civica and GMP requirements.
Establish and maintain Standard Operating Procedures, and training to ensure that all components, raw materials, excipients, drug product containers, closures, in-process materials, packaging material, labelling and drug products are released in accordance with the registered specifications.
Responsible for Quality shop-floor oversight including real-time batch record review, response to deviations and implementation of corrective actions.
Support 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.
Participate in quality risk analysis.
Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
Travel limited but may occasionally be required.
Basic Qualifications and Capabilities
Bachelor's degree in a scientific discipline with a minimum of 5 years Quality/CGMP experience in the pharmaceutical industry. Experience in sterile injectable manufacturing and packaging operations is required.
Strong project management, organization, and execution skills with a proven track record of shop floor manufacturing.
Quality assurance experience across the product development and commercialization lifecycle including.
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.
Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices is highly desirable.
Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
Prior experience in a supervisory role highly desired.