Quality Systems Manager, Pharmaceutical
Posted on: January 16, 2022
About CivicaOver 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, to read a recent article from the New England Journal
of Medicine. Intro to Civica Essential Duties and
- 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
- 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
- Proactively identify and work collaboratively to resolve
problems taking risk-based and compliant approaches to
- Promote a quality mindset and quality excellence approach to
- Maintain written procedures for personnel qualification and
training and support the delivery of compliance training
- 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
- 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
- Excellent interpersonal and written communication skills and
experience using various software/electronic applications
- 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
- 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.
Salary DOE. Excellent benefits.
Keywords: Civica, Richmond , Quality Systems Manager, Pharmaceutical, Executive , Petersburg, Virginia
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