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Manager QA Operations

1 month ago

Fort GreggAdams, United States Civica Rx Full time

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 and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica’s plans and progress at  www.civicarx.org

Job Description:

The Manager Quality Assurance (QA) Operations 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 to ensure requirements for Good Manufacturing Practices (GMPs), are being met leading to a 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, quality disposition of incoming materials and finished drug product, shop floor oversight and the generation, review and/or approval of 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:

  • 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 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.
  • Ensure procedural documents, manufacturing batch records and process within the manufacturing operations are in accordance with FDA regulations and GMPs.
  • Responsible for approving raw materials, excipients, APIs and components material qualifications. 
  • Responsible for ensuring 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.
  • Responsible for labeling processes and management.
  • Responsible for disposition of drug products.
  • 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 or lead in quality risk analysis process transfers.
  • 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.
  • Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.  

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • 8+ years’ experience working directly with manufacturing in the sterile injectable pharmaceutical and packaging operations.
  • Bachelor-level or higher education.
  • Project management, organization, and execution skills are required.
  • Ability to apply technical expertise to solve problems and issues.
  • Experience with technology transfers and new product introduction.
  • Knowledge of data integrity controls in a manufacturing setting.
  • Participation and leading activities to support regulatory agency inspections required.
  • Minimum of 3 years’ experience in a supervisory role.
  • 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.

Preferred Qualifications:

  • Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
  • Experience with isolator technology.
  • Experience with combination products.

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