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QA Operations Manager (366)

Employer
Civica Rx
Location
Petersburg, VA
Start date
Jan 21, 2025
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Job Details

About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. 

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at  www.civicarx.org

Job Description:

The Quality Assurance (QA) Operations 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 sterile injectable medications and combination products. 

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. 

This role will also work closely with external partners and the Civica Petersburg Site for Quality Assurance processes and controls ensuring adherence to applicable regulations for transfer and manufacture of sterile injectable drug product.

Essential Duties and Responsibilities:

  • Manages relationships with external partners for Quality Assurance needs.
  • Liaison between external and internal stakeholders of Quality Assurance and Manufacturing Operations during technology transfer and manufacture of new products.
  • Leads, approves documents and/or participates in change controls, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
  • Leads Quality Assurance manufacturing shop floor support to achieve smooth product transfer and ongoing manufacturing.
  • Drives product and process changes to improve product quality.
  • Reviews and aids in the establishment and maintenance of Quality Agreements Review and Approval of GMP documents such as, but not limited to, Batch Records, Standard Operation Procedures and Technical Transfer Protocols.
  • Proactively identifies and works collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
  • Leads or participates in Quality Risk Management and Data Governance Processes as needed.
  • Leads pre-approval inspection readiness activities.
  • Participates in activities to support regulatory agency inspections.
  • Promotes a quality mindset and quality excellence approach to all activities.
  • Travel is limited but may occasionally be required.

Basic Qualifications and Capabilities:

  • 8+ years’ experience working directly with manufacturing in the sterile injectable pharmaceutical or medical device industries.
  • 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.
  • Familiarity with Annex 1 requirements.
  • Participating in and leading activities that support regulatory agency inspections is 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.


Company

WHY CIVICA?
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. 
 
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 available by 2023.   

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Company info
Website
Location
1 Civica Way
Petersburg
VA
23805
United States

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