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Quality Assurance Manager - Biologics

Company: Civica Rx
Location: Petersburg
Posted on: August 6, 2022

Job Description:

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. 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.

Video Intro to Civica

Job Description
The Quality Assurance Biologics Manager 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 and biosimilar insulin sterile injectable medications. Responsibilities of the position include establishing and maintaining quality and compliance processes associated with sterile manufacturing and operations of biosimilar insulins 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, clinical oversight, batch record review and release of biologic similar insulin bulk drug substance and sterile fill finish vials and pre-filled injectable pen products; developing policies and procedures 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, lead the establishment and maintenance of the site's quality systems related to biological/biosimilar manufacturing operations and packaging to enable the development and reliable supply of Civica medications to patients
  • Responsible for quality oversight of clinical trials
  • Responsible for all operational compliance aspects of sterile fill-finish manufacturing of biological/biosimilar products including but not limited to: batch record review, and batch release
  • Ensure that all aspects of the handling, manufacturing, and distribution of pharmaceutical products at the site comply with Civica and relevant cGMP regulatory requirements
  • Ensure Standard Operating Procedures, and training is in place to maintain compliance with cGMP
  • Provide leadership, direction, and support to the people within the Quality Assurance Operations department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner
  • Maintain current knowledge of local and international biologics regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site
  • Support and ensure compliance of biological/biosimilar products and process transfers, including validation, from and/or to other manufacturing sites
  • 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 or lead quality risk analysis
  • 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
  • Promote a safety mindset and focus on safety for all operations activities
  • Travel (up to 10%) may be required

    Basic Qualifications and Capabilities:

    • Bachelor's degree in a scientific discipline with a minimum of 8 years of Quality/CGMP experience in the pharmaceutical industry.
    • Experience in biological and combination products (i.e. pre-filled injectable pens)
    • Experience in sterile injectable manufacturing and packaging operations is required
    • Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities
    • Quality assurance experience across the product development and commercialization lifecycle including change management and associated implementation strategies
    • Participation and leading activities to support regulatory agency inspections are 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
      PI184661191

Keywords: Civica Rx, Richmond , Quality Assurance Manager - Biologics, Executive , Petersburg, Virginia

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